Psilocybin with psychological support for... — Research Summary & Context

Psilocybin with psychological support for... — Research Summary & Context | Blossom

Abstract

Background

Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species. Recent studies have assessed the therapeutic potential of psilocybin for various conditions, including end-of-life anxiety, obsessive-compulsive disorder, and smoking and alcohol dependence, with promising preliminary results. Here, we aimed to investigate the feasibility, safety, and efficacy of psilocybin in patients with unipolar treatment-resistant depression.

Methods

In this open-label feasibility trial, 12 patients (six men, six women) with moderate-to-severe, unipolar, treatment-resistant major depression received two oral doses of psilocybin (10 mg and 25 mg, 7 days apart) in a supportive setting. There was no control group. Psychological support was provided before, during, and after each session. The primary outcome measure for feasibility was the patient-reported intensity of psilocybin's effects. Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up. Depressive symptoms were assessed with standard assessments from 1 week to 3 months after treatment, with the 16-item Quick Inventory of Depressive Symptoms (QIDS) serving as the primary efficacy outcome. This trial is registered with ISRCTN, number ISRCTN14426797.

Findings

Psilocybin's acute psychedelic effects typically became detectable 30-60 min after dosing, peaked 2-3 h after dosing, and subsided to negligible levels at least 6 h after dosing. Mean self-rated intensity (on a 0-1 scale) was 0·51 (SD 0·36) for the low-dose session and 0·75 (SD 0·27) for the high-dose session. Psilocybin was well tolerated by all of the patients, and no serious or unexpected adverse events occurred. The adverse reactions we noted were transient anxiety during drug onset (all patients), transient confusion or thought disorder (nine patients), mild and transient nausea (four patients), and transient headache (four patients). Relative to baseline, depressive symptoms were markedly reduced 1 week (mean QIDS difference −11·8, 95% CI −9·15 to −14·35, p=0·002, Hedges' g=3·1) and 3 months (−9·2, 95% CI −5·69 to −12·71, p=0·003, Hedges' g=2) after high-dose treatment. Marked and sustained improvements in anxiety and anhedonia were also noted.

Interpretation

This study provides preliminary support for the safety and efficacy of psilocybin for treatment-resistant depression and motivates further trials, with more rigorous designs, to better examine the therapeutic potential of this approach.

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Research Summary of 'Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study'

Introduction

Psilocybin is a naturally occurring psychedelic prodrug of psilocin that produces its principal psychoactive effects via serotonin 2A (5-HT2A) receptor agonism. Earlier preclinical and human imaging work has linked 5-HT2A receptor agonism with cognitive and neural plasticity changes and with antidepressant-like effects, and modern clinical studies of psychedelics have reported reductions in anxiety, depressive symptoms, and addictive behaviours after one or two exposures. At the same time, depression remains a major global health burden and a substantial minority of patients do not respond to available treatments, creating a need for new interventions for treatment-resistant depression. Carhart-Harris and colleagues designed this open-label feasibility study to assess whether a protocol of two supervised oral psilocybin administrations, given with psychological support, could be safely delivered to patients with unipolar treatment-resistant major depression and to obtain an initial impression of clinical effects. Their prespecified primary feasibility outcome was patient-rated subjective intensity of psilocybin's effects; the principal efficacy endpoint was change in self-reported depressive symptoms (16-item QIDS) from baseline to 1 week after the high-dose session. The investigators hypothesised that the intervention would be well tolerated and produce substantial reductions in depressive symptoms lasting up to 3 months.

Methods

This was an open-label, single-arm feasibility trial with no control group and no masking of participants, investigators, raters, or statisticians. The intended recruitment for the imaging protocol was 20 patients, but the present report covers the first 12 participants enrolled. Inclusion criteria required major depression of moderate to severe degree (HAM-D ≥17) and failure to improve after at least two adequate antidepressant courses of different pharmacological classes during the current episode. Exclusion criteria included current or past psychotic disorder, a first-degree relative with a psychotic disorder, medically significant conditions, history of serious suicide attempts requiring hospitalisation, history of mania, blood or needle phobia, pregnancy, and current drug or alcohol dependence. Recruitment was via general practitioner networks and self-referral; in every case the patient's clinician provided written documentation of diagnosis and history. Procedures combined preparatory psychological work, two dosing sessions separated by 7 days, and follow-up. After medical screening (ECG, blood tests, vitals) and a baseline 60-minute fMRI scan, patients undertook an extensive preparatory psychological session (typically about 4 hours) with the two psychiatrists who would provide support. Dosing occurred in a calm, music-supported clinical room with at least two staff present. Patients received an initial low oral dose of psilocybin 10 mg and, 7 days later, a treatment dose of 25 mg. Physiological monitoring and observer ratings of acute effects were recorded at baseline and at multiple timepoints up to 360 minutes postdose; subjective altered-state effects were assessed 6–7 hours after dosing using the 11-dimension ASC questionnaire. Tranquillising medications (oral lorazepam and risperidone) were available but not used. Follow-up included a telephone check 1 day after the low dose, a posttreatment fMRI and clinical assessment 1 day after the high dose, an in-person 1-week follow-up with repeat assessments and debriefing, email-based clinical questionnaires at 2, 3, and 5 weeks (QIDS only), and a final remote assessment at 3 months that included QIDS, BDI, STAI-T, and SHAPS. The primary feasibility outcome was patient-rated subjective intensity of psilocybin on a 0–1 scale. The primary efficacy outcome was mean change in QIDS from baseline to 1 week after the high-dose session; secondary measures included BDI, STAI-T, SHAPS, HAM-D, MADRS, and GAF at specified timepoints. No formal power calculation was performed for this feasibility report; statistical analyses used two-tailed Wilcoxon signed-rank tests for non-parametric comparisons and two-tailed t tests where appropriate, with 95% confidence intervals reported for mean differences.

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INTRODUCTION

Psilocybin is a naturally occurring plant alkaloid found in the Psilocybe genus of mushrooms. Psilocybe mushrooms have been used for millennia for healing purposes, but were only discovered by modern science in the late 1950s.Psilocybin is a prodrug of psilocin (4-hydroxy-dimethyltryptamine), a serotonin receptor agonist and classic psychedelic drug whose principal psychoactive eff ects are mediated by serotonin 2A (5-HT 2A ) receptor agonism.Psilocybin therefore has a novel pharmacology in the context of currently available antidepressant medications, because selective serotoninreuptake inhibitors are not direct 5-HT 2A receptor agonists. Enhanced cognitive fl exibility,associative learning, 5 cortical neural plasticity,and antidepressant responses have been reported with 5-HT 2A receptor agonism in animals,and increased and sustained improvements in wellbeingand optimismhave been observed after psychedelic experiences in human beings. Findings from human imaging studies with psilocybin have supplemented these discoveries, showing changes in brain activity suggestive of antidepressant potential; for example, a range of eff ective antidepressant treatments have been found to normalise hyperactivity in the medial prefrontal cortex and we found reduced blood fl ow in this region with intravenous psilocybin.Moreover, data obtained from large-scale population studies have recently challenged the view that psychedelics negatively aff ect mental health,with one study's fi ndings showing lower rates of psychological distress and suicidality among people who had used psychedelics within their lifetime than among those who used no psychedelics but an equivalent amount of other drugs.In modern trials, psychedelics have been found to reduce anxious,depressive,and obsessivecompulsive symptoms,as well as addictive behaviours,often for several months after just one or two exposures. Extensive historical and modern evidence now supports the view that, administered in a controlled environment with appropriate support, psychedelics have a favourable safety profi le.Depression is a major public health problem; it is a leading contributor to the global burden of disease, aff ecting hundreds of millions of people worldwide, and costing the USA alone more than US$200 billion each year.Antidepressant medications and cognitive behavioural therapy can be eff ective for some patients, but around 20% do not respond to any intervention, and many of those who do respond, eventually relapse.We aimed to investigate the safety and feasibility of psilocybin in patients with treatment-resistant depression, and to establish an initial impression of its effi cacy. We postulated that the treatment would be well tolerated and depressive symptoms would be substantially reduced from baseline at all assessment points, for up to 3 months after treatment.

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Study Details

Study Type
individual
Population
humans
Characteristics
open labelfollow up
Journal
Lancet Psychiatry
Compound
Psilocybin
Topics
Anxiety Disorders Depressive Disorders Adolescents Major Depressive Disorder (MDD)

Results

Between May and August 2015, 72 people were initially considered, 38 underwent telephone screening, 18 were invited for formal screening, and 12 patients were ultimately enrolled (ten self-referrals). Baseline clinical severity was high: nine of 12 met criteria for severe or very severe depression (BDI ≥30) and the remaining three met criteria for moderate depression (BDI 19 to <30). Most participants (11 of 12) had received prior psychotherapy. All participants completed the two-dose protocol. Mean self-rated intensity of the psilocybin experience was 0.51 (SD 0.36) for the 10 mg session and 0.75 (SD 0.27) for the 25 mg session. Acute psychedelic effects typically emerged between 30 and 60 minutes, peaked between 2 and 3 hours, and subsided to negligible levels by about 6 hours, at which point discharge assessment occurred. No participant required the available tranquilising medications. Adverse events were generally transient and expected: mild transient anxiety at onset (n=12), transient confusion or thought disorder (n=9), mild transient nausea (n=4), and transient headache (n=4). One patient experienced mild, transient paranoia. No prolonged psychotic symptoms or serious or unexpected adverse events were observed. During 3 months of follow-up one participant contacted the study psychiatrists for deteriorating depression and was referred back to their general practitioner. Clinically, self-reported depressive symptoms (QIDS) were significantly reduced relative to baseline at 1 week and at 3 months after the high-dose session, with the largest mean effect observed at 2 weeks. BDI and clinician-administered ratings (HAM-D, MADRS, GAF) confirmed these improvements at 1 week. By standard remission criteria on the BDI (score ≤9), eight of 12 patients (67%) achieved complete remission at 1 week. At 3 months, seven patients (58%) continued to meet response criteria (≥50% reduction in BDI from baseline), and five patients (42%) remained in complete remission. Anxiety (STAI-T) and anhedonia (SHAPS) scores were also significantly reduced at both 1 week and 3 months. The investigators noted that while all patients showed some improvement for at least 3 weeks, five participants displayed a degree of relapse by 3 months.

Discussion

Carhart-Harris and colleagues interpret these findings as supportive of the feasibility and tolerability of supervised psilocybin administration with psychological support in people with unipolar treatment-resistant depression, and they regard the observed reductions in depressive symptoms as sufficient to justify further controlled research. The reported 1-week response/remission rates (67% remission on BDI at 1 week) and the persistence of response in a majority at 3 months are highlighted as notable, particularly given the long illness durations in this sample. The investigators position these results within prior psychedelic literature showing rapid and sustained improvements after one or two administrations in conditions such as end-of-life anxiety, substance dependence, and smoking cessation. They note that psilocybin's pharmacology (direct 5-HT2A agonism) differs from current antidepressants and might underlie distinct therapeutic mechanisms. Key limitations acknowledged by the authors include the open-label, single-arm design and small sample size, which preclude strong efficacy conclusions and leave the results vulnerable to expectancy and self-selection biases, especially since most participants self-referred. The combination of drug administration and substantial psychological support and a positive therapeutic setting makes it impossible in this design to disentangle the relative contributions of pharmacology versus contextual and psychotherapeutic factors. The authors also caution about inflated effect sizes in early-phase trials and note that five participants showed partial relapse by 3 months. Practical considerations for future trials include the likely need to control for concomitant serotonergic antidepressants, since chronic SSRI use can downregulate 5-HT2A receptors and attenuate psychedelic responses. For future research the authors propose randomised, placebo-controlled designs with equivalent therapist contact between arms, consideration of active placebos to preserve blinding, and comparative trials versus other rapid-acting interventions (for example, ketamine). They also suggest measuring and managing expectancy and suggestibility, which may be influential in psychedelic therapies and could be treated either as confounds or as components of the therapeutic model. Overall, the investigators conclude that their data support further rigorous trials to examine psilocybin's potential as a novel treatment for treatment-resistant depression.

STUDY DESIGN AND PARTICIPANTS

This was an open-label feasibility study in patients with treatment-resistant depression; there was no control group. Patients, invest igators, raters, and statisticians were not masked to treatment assignment, and all participants received the study intervention (psilocybin administered in two dosing sessions; an initial safety [low] dose and a subsequent treatment [high] dose). The inclusion criteria were major depression of a moderate to severe degree (17+ on the 21-item Hamilton Depression Rating scale [HAM-D]), and no improvement despite two adequate courses of antidepressant treatment of diff erent pharmacological classes lasting at least 6 weeks within the current depressive episode.Exclusion criteria were: current or previously diagnosed psychotic disorder; immediate family member with a diagnosed psychotic disorder; medically signifi cant condition rendering unsuitability for the study; history of serious suicide attempts (requiring hospitalisation); history of mania; blood or needle phobia; positive pregnancy test at screening or during the study; and current drug or alcohol dependence. Information about the study's recruitment was sent to general practitioners via the North West London Clinical Research Network. However, patients were also allowed to self-refer to the study if they were UK residents. In every case, patients initiated contact with the research team (via email, letter, or telephone), were sent a study information sheet, and a subsequent telephone screening was arranged, during which the lead psychiatrist on the trial (MBo) obtained information about the patient's demographics, medical and psychiatric history, and other key inclusion or exclusion criteria. The patient's general practitioner or psychiatrist provided written documentation of the patient's diagnosis and mental health background in every case. This trial received a favourable opinion from the National Research Ethics Service London-West London, was sponsored and approved by Imperial College London's Joint Research and Compliance Offi ce (JRCO), and was adopted by the National Institute for Health Research Clinical Research Network. The National Institute for Health Research/Wellcome Trust Imperial Clinical Research Facility gave site-specifi c approval for the study.

PROCEDURES

Psilocybin was obtained from THC-pharm (Frankfurt, Germany) and formulated into the investigational medicinal product (5 mg ). Patients also received a thorough physical health check, consisting of an electrocardiogram, routine blood tests, blood pressure, heart rate, and physical examination. At the end of screening, eligible patients were given an opportunity to meet with the two clinical psychiatrists who would support them through the remainder of the trial. Eligible patients attended a subsequent visit involving a baseline functional MRI (fMRI) scanning session lasting 60 min, followed by an extensive preparatory session with their allocated psychiatrists; fMRI data will be reported elsewhere. This preparatory session involved inviting the patient to talk openly about their personal history (including thoughts on the origins of their depression), a discussion of psilocybin's psychological eff ects, and simulation of aspects of the dosing session itself, such as listening to a sample of the session music while wearing eyeshades. The preparatory session typically lasted for 4 h, with lunch and breaks provided. Patients enrolled in the study attended two subsequent dosing sessions that were separated by 7 days. No more than one patient was dosed on any given day. Patients arrived at the research facility (Imperial Clinical Research Facility) at 0900 h, gave a urine sample for drugs of abuse (including amphetamines, benzodiazapines, opiates, and cannabinoids), performed a breathalyser test for alcohol use, and completed interim QIDS, BDI, and STAI-T assessments to ensure no substantial deviation from baseline measures. They were then taken to a dosing room that was pre-decorated (eg, with low lighting). Patients were invited to relax on a ward bed in a supine or reclined position and music was played through high-quality stereo speakers and earphones. The two psychiatrists sat on either side of the bed. Patients were supervised at all times by at least two staff members. Dosing commenced at 1030 h in every case. Patients received a low oral dose of psilocybin 10 mg (two 5 mg capsules) on a fi rst dosing day and a high oral dose of psilocybin 25 mg (fi ve 5 mg capsules) on a second dosing day, separated by 1 week. Blood pressure, heart rate, and observer ratings of the intensity of psilocybin's acute psychoactive eff ects (0-4, with 0 signifying no eff ects and 4 signifying extreme eff ects 8 ) were measured at baseline (typically 5 min before dosing) and 30, 60, 120, 180, 240, 300, and 360 min after dosing. Subjective ratings of the acute altered state of consciousness using the revised 11 dimension altered states of consciousness questionnaire (11D ASC)were completed 6-7 h after dosing. Psychiatrists adopted a non-directive, supportive approach, allowing the patient to experience a mostly uninterrupted inner "journey". Check-ins (ie, asking the patient how they are feeling) occurred at the same timepoints as the physiological recordings. Tranquilising medications (oral lorazepam and risperidone) were available if necessary. The phenomenology of the acute experience, including accounts of the nature of the therapeutic support provided before, during, and after the experience, and considerations related to the music selection and other aspects of the clinical setting, will be discussed in separate publications. Return transport from the research facility was organised ahead of dosing sessions. Patients were taken to and from the sessions accompanied by a close friend or relative, and had the option of staying overnight in accommodation adjacent to the hospital. Emergency contact details were provided, and patients confi rmed their safe return from the research facility. Patients were contacted via telephone 1 day after their low-dose session to check on their wellbeing and monitor for any adverse events. Patients returned to the research facility 1 day after their high-dose session for a posttreatment fMRI scan lasting 60 min. After the fMRI scan, patients completed interim questionnaires (QIDS, STAI-T, and HAM-D), and were invited back to the research facility where they were met by their psychiatrists to discuss their experience the previous day. Patients attended one further study visit to the research facility 1 week after their high-dose session, during which all baseline questionnaires and assessments were repeated and an opportunity was provided for further psychological debriefi ng (the 1 week follow-up visit). Assessments of HAM-D, MADRS, and GAF were again done by MBo. Subsequent assessments of clinical progress were done via email 2, 3, and 5 weeks after the high-dose session; we assessed only QIDS during subsequent follow-up, so as not to overload the patient. Final follow-up was done remotely at 3 months after the high-dose session, and included QIDS, BDI, STAI-T, and SHAPS. Patients were made aware that they could contact the study psychiatrists at any time if their depression deteriorated. Figuresummarises the screening, intervention, and follow-up procedures in this study.

TABLE 1: BASELINE AND DEMOGRAPHIC CHARACTERISTICS, BY PATIENT

No patients required tranquilising medications (oral lorazepam and risperidone) during the dosing sessions. Psilocybin's acute psychedelic effects typically became detectable between 30 min and 60 min after dosing, peaked between 2 h and 3 h after dosing, and subsided to negligible levels at which the patient could be assessed for discharge at least 6 h after dosing (appendix). Self-rated experiences on the 11D-ASC questionnaire from the two sessions are shown in the appendix. Results from interim patient questionnaires (QIDS, BDI, and STAI-T), done immediately before the low-dose session to monitor for substantial changes since enrolment, did not differ from baseline (data not shown). Interim questionnaires done the day after the high-dose session showed some reduction in depressive symptoms (data for HAM-D in appendix; data for QIDS and STAI-T not shown). The most common adverse events were transient anxiety (mostly mild) during drug onset (n=12), transient confusion or thought disorder (n=9), mild and transient nausea (n=4), and transient headache (n=4; table). These adverse events were expected psychological eff ects of psilocybin. Subacute headache typically presented 1 day after the psilocybin session, and subsided after 1-2 days. Paranoia presented in only one patient, but this was mild and transient. No prolonged psychotic symptoms were observed in any of the patients. One patient contacted the study psychiatrists during the 3 months of follow-up due to deterioration of their depression, and was referred to their general practitioner. QIDS depression scores were signifi cantly reduced from baseline to 1 week and 3 months post-treatment, with the maximum eff ect at 2 weeks (fi gure 3, table). BDI and clinician-administered ratings confi rmed these results (fi gure 4, table). All patients showed some reduction in depression severity at 1 week that was sustained in the majority for 3 months (appendix). According to standard criteria for determining remission (eg, a score of ≤9 on the BDI), eight (67%) of the 12 patients achieved complete remission at 1 week and seven patients (58%) continued to meet criteria for response (50% reduction in BDI score relative to baseline) at 3 months, with fi ve of these (42%) still in complete remission (fi gure 4, table). STAI-T anxiety scores were also signifi cantly reduced at 1 week and 3 months post-treatment, as were SHAPS anhedonia scores for 1 week and 3 months post-treatment (table).

DISCUSSION

In this open-label, single-arm pilot study, we sought to examine the feasibility of administering psilocybin to patients with treatment-resistant depression as a prelude to a larger randomised controlled trial. Our results support Because this was a small-scale feasibility study with an open-label design, strong inferences cannot be made about the treatment's therapeutic effi cacy. However, the data do suggest that further research is warranted. The response rate to psilocybin was 67% (n=8) at 1 week after treatment (HAM-D and BDI), and seven of these eight patients also met criteria for remission. Moreover, 58% (n=7) of the patients maintained their response for 3 months, and 42% (n=5) remained in remission. It is also worth noting that psilocybin has a favourable toxicity profi le and is not associated with compulsive drug-seeking behaviours in animals or human beings. The side-eff ects that we noted were minor, and expected in light of previous studies of psilocybin.Spontaneous recovery in refractory depression is rare, and many of the patients in the present study reported having depression for much of their adult lives (mean estimated illness duration 17•8 years [SD 8]). Key questions for future research therefore should address why the therapeutic eff ect observed in the present study is so large, and if it can be replicated when tighter experimental controls are introduced. Because the treatment in our study consisted of not just two psilocybin administrations but also psychological support before, during, and after these sessions, as well as a positive therapeutic environment for the sessions, the relative eff ects of these factors need to be determined, which can only be done by conducting further trials with appropriate control conditions. A logical next step would be to carry out a placebocontrolled randomised trial in which the level of therapist contact is consistent between conditions. This would enable any between-group diff erences in clinical outcomes to be attributed to psilocybin rather than the psychological support provided. However, a positive interaction between these variables seems likely, and inert placebo-based blinds are known to be ineff ective in studies involving conspicuous experimental interventions, because patients can easily discern whether they are in the active condition or not. Use of an active placebo for the control condition might therefore be worth considering. Additionally, randomised comparative effi cacy trials (eg, with an optional crossover component) incorporating another treatment for refractory depression (eg, ketamine infusion) could also be explored. The magnitude and persistence of the antidepressant eff ects observed here are not incongruent with what has been observed previously with psilocybin in chronic psychiatric conditions. For example, 80% of long-term heavy tobacco smokers demonstrated abstinence from smoking 6 months after two treatment sessions with psilocybin.Alcohol-dependent patients demonstrated signifi cantly reduced drinking behaviours over 8 months after one or two psilocybin sessions.Signifi cantly decreased anxiety and depression scores were observed 3 and 6 months after a single dose of psilocybin in patients with anxiety related to end-stage cancer,and improve ments in wellbeing lasting for more than 1 year were observed in healthy individuals given a single dose of psilocybin.Rapid and enduring decreases in depressive symptoms were also recently found in a small-scale feasibility trial involving the psychedelic brew, ayahuasca.It is important to consider the limitations of this pilot study; for example, although all patients showed some clinical improvements for at least 3 weeks after treatment, and no serious or unexpected adverse reactions were observed, enduring improvements beyond 3 weeks were not observed universally, and fi ve of the 12 patients showed a degree of relapse at 3 months. One should be cautious of the potential for infl ated eff ect sizes in early trials, particularly when the sample size is small. That all patients showed some improvement in their depressive symptoms for up to 3 weeks after treatment could be suggestive of an expectancy bias. It may also be relevant that most patients in this trial were self-referring and, thus, actively sought this treatment. Psychedelics are known to promote suggestibility,which might have further enhanced positive outcomes. Future double-blind randomised controlled trials could address the role of expectancy and suggestibility by measuring and controlling these variables. For example, patients could be asked about their pre-treatment expectations, suggestions could be controlled between conditions, and outcomes from self-referred patients could be compared with those from patients referred via clinicians. From a more pragmatic perspective, if expectancy or suggestibility are found to be infl uential in the context of psychedelic therapy, they could be treated as exploitable components of the treatment model rather than confounding variables. Serotonergic antidepressants have been found to downregulate the primary receptor target of psilocybin (the 5-HT 2A receptor) and attenuated subjective responses to psychedelics have previously been reported in individuals chronically medicated with serotonergic antidepressants.Thus, patients may be required to withdraw from concurrent antidepressant medication before receiving psilocybin and this should only ever be done with care. In conclusion, we sought to assess the safety and tolerability of psilocybin plus psychological support in patients with unipolar treatment-resistant depression. Our fi ndings support the feasibility of this approach and the magnitude and duration of the post-treatment reductions in symptom severity motivate further controlled research. Psilocybin has a novel pharmacological action in comparison with currently available treatments for depression (ie, 5-HT 2A receptor agonism) and thus could constitute a useful addition to available therapies for the treatment of depression.

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Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depression: a pilot study (PSILODEP-PILOT)

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Abstract

Research Summary of 'Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study'

Introduction

Methods

INTRODUCTION

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Study Details

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Results

Discussion

STUDY DESIGN AND PARTICIPANTS

RESEARCH IN CONTEXT

ADDED VALUE OF THIS RESEARCH

IMPLICATIONS OF ALL THE AVAILABLE EVIDENCE

PROCEDURES

OUTCOMES

STATISTICAL ANALYSIS

ROLE OF THE FUNDING SOURCE

RESULTS

TABLE 1: BASELINE AND DEMOGRAPHIC CHARACTERISTICS, BY PATIENT

DISCUSSION

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