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Home/Research/Placebo/Suicidality

Placebo for Suicidality

13 papers and 59 clinical trials exploring placebo as a treatment for suicidality.

CompoundComparator / Control

Placebo

Placebo is the most widely referenced comparator in psychedelic clinical research, appearing in over 500 trials. Understanding how placebos are designed, administered, and interpreted is essential to evaluating the evidence base for psychedelic-assisted therapies — and one of the field’s most contested methodological challenges.

Full Placebo profile
IndicationMore than 727,000 deaths by suicide worldwide each year

Suicidality

Suicidality covers the spectrum of suicidal thoughts, plans and behaviours, and it contributes to more than 727,000 deaths worldwide each year. The strongest evidence for rapidly reducing suicidal thinking is for ketamine and esketamine, and esketamine carries a specific regulatory approval. But even there, a reduction in suicide itself has not been proven, and classic psychedelics remain unproven for suicidality and can carry real risks for people in crisis. This is a research summary, not medical advice.

Full Suicidality profile

Academic Research

13 papers
Open Accessindividual

Low-Dose Buprenorphine Following Ketamine Treatment for Suicidal Ideation in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

This randomised, double-blind, placebo-controlled trial (n=50) tested low-dose sublingual buprenorphine after ketamine in adults with major depressive disorder and suicidal thoughts. Buprenorphine led to a greater and longer-lasting reduction in suicidal ideation than placebo, while depression scores were similar and no serious treatment-related side effects occurred.

Published
May 18, 2026
Journal
American Journal of Psychiatry
Authors
Tucciarone, J. M., Bandeira, I. D., Blasey, C., Kratter, I. H., Ehrie, J., Keller, J., Pankow, H., Chang, M., Hawkins, J., Evers, A. G., Bernert, R., DeBattista, C., Truong, H., Rodriguez, C. I., Heifets, B. D., Schatzberg, A. F.
Open Accessindividual

Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression: The EPISODE Randomized Clinical Trial

In this triple‑blind, active placebo‑controlled randomised trial (n=144) of adults with treatment‑resistant depression, two 25 mg doses of psilocybin plus adjunct psychotherapy produced clinically meaningful reductions in depressive symptoms on exploratory secondary measures but did not significantly improve the pre‑second‑dose HAMD17 response rate versus nicotinamide.

Published
March 18, 2026
Journal
JAMA Psychiatry
Authors
Mertens, L. J., Koslowski, M., Betzler, F., Brand, M., Evens, R., Kärtner, L., Jungaberle, A., Jungaberle, H., Majić, T., Schmitz, C. N., Ströhle, A., Scharf, D., Spangemacher, M., Wolff, M., Assadi, Z., Bahri, S., Becher, L., Färber, L. V., Kirchen, N., Kulakova, E., Kunz, L., Meijer, A., Rohrmoser, B., Wellek, S., Berger, M. M., Gründer, G.
Open Accessindividual

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study

This double-blind, randomised, placebo-controlled Phase I study (n=48) evaluates the safety, pharmacokinetics, and psychoactive effects of RE104 (psilocybin analog; Luvesilocin; a prodrug of 4-OH-DiPT) in healthy adults with prior psychedelic experience. RE104 was well tolerated up to 40 mg with no serious adverse events, and plasma levels of its active form correlated with subjective drug effect and mystical experience scores. The compound produced psilocybin-like effects with a shorter duration (3-4 hours), supporting further therapeutic investigation.

Published
July 21, 2025
Journal
Journal of Clinical Psychopharmacology
Authors
Ludbrook, G., Bryson, N., Taylor, B., Hocevar-Trnka, J., Johnson, M. W., Hirman, J., Morrish, G., Alexander, R., Pollack, M.
Paywallmeta

The impact of psychedelics on patients with alcohol use disorder: a systematic review with meta-analysis

This systematic review and meta-analysis (s=6; 2023) assessed the role of psychedelics in treating alcoholism (AUD). LSD and any psychedelic therapy showed enhanced odds of achieving abstinence or reducing alcohol consumption in randomised, double-blind, placebo-controlled trials. However, the study highlights methodological weaknesses in the literature. It suggests that while promising, definitive statements about the value of psychedelics in treating AUD are precluded, emphasizing the need for future trials with greater rigour.

Published
December 18, 2023
Journal
Current Medical Research and Opinion
Authors
Sicignano, D., Hernandez, A. V., Schiff, B., Elmahy, N., White, C. M.
Open Accessindividual

Intranasal esketamine effectively treats treatment-resistant depression in adults regardless of baseline irritability

This post hoc analysis of two Phase III double-blind studies assessed the effects of baseline irritability on clinical outcomes in participants with treatment-resistant depression (TRD) (n=560) treated with intranasal ketamine (esketamine) plus an oral antidepressant (ESK + AD). ESK + AD improved symptoms of depression regardless of baseline irritability level and increased odds of achieving a response in all participants.

Published
October 20, 2022
Journal
Journal of Affective Disorders
Authors
Jha, M. K., Williamson, D. J., Magharehabed, G., Turkoz, I., Daly, E. J., Trivedi, M. H.
Paywallindividual

The potential pro-cognitive effects with intravenous subanesthetic ketamine in adults with treatment-resistant major depressive or bipolar disorders and suicidality

This single-blind, placebo-controlled study (n=111) assessed the cognitive effects of six ketamine infusions (35 mg/70 kg) in patients with unipolar or bipolar depression. Results indicate that ketamine improved processing speed independently of its antidepressant effects, while improvements in verbal learning were mediated by reductions in depressive symptoms.

Published
October 23, 2021
Journal
Journal of Psychiatric Research
Authors
Zhou, Y-L., Wang, C., Lan, X-F., Zheng, W., Chao, Z., McIntyre, R. S., Ning, Y-P., Li, H., Wu, K.

Clinical Trials

59 trials
Not yet recruitingPhase II

Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)

This Phase II randomised, quadruple-masked trial (n=120) will study adults aged 18 to 70 years with borderline personality disorder, treatment-resistant major depressive disorder or bipolar disorder, and suicidal ideation, evaluating whether intravenous ketamine plus dialectical behavioural therapy (DBT) reduces suicidal ideation more rapidly and robustly than midazolam plus DBT. The main purpose is to assess change in suicidal ideation severity from baseline to Day 35 using the Modified Scale for Suicidal Ideation (MSSI). All participants will receive DBT for 6 months, starting before the infusions, with weekly individual sessions and the addition of weekly group sessions from Week 5. The experimental arm will receive six intravenous ketamine infusions over 1 month: the first two at 0.5 mg/kg over 40 minutes, infusions 3 and 4 flexibly dosed at 0.5 mg/kg to 0.75 mg/kg, and infusions 5 and 6 flexibly dosed at 0.5 mg/kg to 0.85 mg/kg. The comparator arm will receive six intravenous midazolam infusions over the same period: the first two at 0.02 mg/kg over 40 minutes, infusions 3 and 4 at 0.02 mg/kg to 0.03 mg/kg, and infusions 5 and 6 at 0.2 mg/kg to 0.035 mg/kg. Participants will also complete hospital visits, remote follow-up by call or videocall, and a range of mood, cognitive and behavioural assessments.

Started
June 1, 2026
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT07569198
WithdrawnPhase II

Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies

This Phase II, non-randomised, open-label, parallel-group trial (n=150) will study response to three neuroplasticity-enhancing interventions in civilian and Veteran adults (aged 18–69) at low, intermediate or high risk for self-harm. The study will evaluate clinical change in suicidal ideation (Scale of Suicidal Ideation from baseline to the post‑treatment visit at Month 6) and aim to characterise neurobiological and blood-based markers associated with risk and treatment response. Participants are allocated to one of three experimental arms: two sessions of fMRI neurofeedback targeting amygdala activity, an accelerated theta burst stimulation programme of 50 sessions delivered to the dorsolateral prefrontal cortex, or psilocybin‑assisted therapy comprising three preparation sessions, two psilocybin administration sessions and two integration sessions. Baseline and post‑treatment assessments include clinical measures, structural and functional MRI and blood sampling for circular RNA (circRNA); an artificial intelligence analytic team will use these multimodal data to develop predictive models of behavioural risk and treatment response.

Started
May 1, 2026
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07484906
Enrolling by invitationPhase NA

Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation

This interventional trial (n=56) will evaluate the effects of combined intranasal esketamine and brief cognitive behavioural therapy for suicide prevention (BCBT-SP) in patients experiencing suicidal ideation associated with treatment-resistant depression (TRD). The primary aim is to assess reductions in suicidal ideation at one week post-treatment, comparing the combined treatment group with a control group receiving only intranasal esketamine. Participants aged 18 to 70 with a major depressive episode and ongoing suicidal ideation will be recruited. The trial will consist of two arms: one receiving naturalistic intranasal esketamine and the other receiving BCBT-SP alongside intranasal esketamine, involving 12 weekly sessions of psychotherapy. Key outcome measures include the Beck Scale for Suicidal Ideation and TMS-EEG N100 peak, both assessed one week after treatment. The study is set to begin in January 2026 and is expected to complete by January 2029.

Started
January 9, 2026
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT07396220
RecruitingPhase III

A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder (AVENUE)

This Phase III, double-blind, randomised, placebo-controlled trial (n=258) will evaluate the efficacy and safety of intranasal esketamine 84 mg in addition to comprehensive standard of care for rapidly reducing symptoms of major depressive disorder (MDD) in adolescent participants aged 12 to 17 with acute suicidal ideation or behaviour. The primary outcome is the change in depressive symptoms measured by the Children's Depression Rating Scale - Revised (CDRS-R) total score at 24 hours post-first dose. Participants will be randomly assigned to receive either intranasal esketamine (84 mg, with potential dose adjustments to 56 mg) plus oral placebo or intranasal placebo plus oral midazolam (0.0625 mg/kg) twice weekly for four weeks. The treatment will occur on specific days, with assessments conducted to monitor the efficacy and safety of the interventions. The trial is sponsored by Janssen Research & Development, LLC, with an estimated start date of January 8, 2026, and a completion date of September 15, 2031.

Started
January 8, 2026
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT07227454
Not yet recruitingPhase III

Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and/or Behavior in Adolescents

This randomised, double-blind, placebo-controlled Phase III trial (n=60) will investigate the efficacy and safety of subcutaneous ketamine (35-70mg/70kg, twice weekly for four weeks) as an add-on treatment for adolescents experiencing a major depressive episode with suicidal ideation and/or behaviour.

Started
May 1, 2025
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06957704
RecruitingPhase I

PsiloIMAGINE: A Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm

This triple-blind, placebo-controlled trial (n=30) will investigate the effects of a sub-hallucinogenic dose of psilocybin (5 mg) combined with Imagery Re-Scripting (ImRS) on cognitive processes and self-harm behaviour in young people aged 16–25.

Started
March 1, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06798636

Explore further

Search all Placebo papers Search all Suicidality trials Full Placebo profile Full Suicidality profile