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Home/Research/Placebo/Bipolar Disorder

Placebo for Bipolar Disorder

6 papers and 25 clinical trials exploring placebo as a treatment for bipolar disorder.

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
Indication45 million worldwide

Bipolar Disorder

Bipolar disorder, characterised by extreme fluctuations in mood, is a complex mental health condition that affects approximately 45 million people worldwide. Current research on psychedelics as a potential treatment is limited due to concerns about inducing manic episodes, but emerging evidence, particularly regarding ketamine, suggests promise for alleviating depressive symptoms associated with the disorder.

Full Bipolar Disorder profile

Academic Research

6 papers
Open Accessmeta

International pooled patient-level meta-analysis of ketamine infusion for depression: In search of clinical moderators

This meta-analysis (n=809, s=17) finds robust effects of ketamine for relieving depression (at 24 hours and seven days). Moderators of this effect were the level of treatment resistance (i.e. more failed SSRIs) and studies that used a cross-over design (smaller placebo effect). Other moderators were found, but all were modest and clinically irrelevant (i.e. age or sex doesn't moderate treatment effect).

Published
September 7, 2022
Journal
Molecular Psychiatry
Authors
Price, R., Kissel, N., Baumeister, A., Rohac, R., Woody, M. L., Ballard, E. D., Zarate, C. A., Deakin, W., Abdallah, C. G., Feder, A., Charney, D. S., Grunebaum, M. F., Mann, J. J., Mathew, S. J., Gallagher, B., McLoughlin, D. M., Murrough, J. W., Muthukumaraswamy, S., McMillan, R., Sumner, R. L., Papakostas, G. I., Fava, M., Hock, R. S., Phillips, J. L., Blier, P., Shiroma, P. R., Sos, P., Chen, M. H., Tiger, M., Lundberg, J., Wilkinson, S. T., Wallace, M. L., Su, T. P.
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.
Open Accessmeta

Ketamine for bipolar depression: a systematic review

This review (2021; s=6; n=135) found that ketamine (35mg/70kg; 1-6 doses) achieved a response (>50% reduction) on a score of depression for 61% of those suffering from bipolar depression (BD), compared to 5% for placebo.

Published
April 30, 2021
Journal
International Journal of Neuropsychopharmacology
Authors
Bahji, A., Zarate, C. A., Vazquez, G. H.
Open Accessmeta

Ketamine for the treatment of major depressive disorder and bipolar depression: A review of the literature

This literature review (2017) of randomised, placebo-controlled trials explores the effects of ketamine in treatment-resistant depression (TRD) and bipolar depression (BD). Ketamine reduced symptoms in both and is a promising compound for those who have found other treatments lacking.

Published
January 1, 2017
Journal
Mental Health Clinician
Authors
Grady, S. E., Marsh, T. A., Tenhouse, A., Klein, K.
Open Accessmeta

Meta-analysis of short- and mid-term efficacy of ketamine in unipolar and bipolar depression

This meta-analysis (2015) of six randomised, double-blind, placebo-controlled trials (n=101) examined the short-and mid-term efficacy of ketamine (bipolar) to depression. Ketamine effectively reduced symptoms in unipolar depression for seven days, , whereas the maintenance of its efficacy in bipolar depression failed to reach significance after 4 days.

Published
December 15, 2015
Journal
Psychiatry Research
Authors
Romeo, B., Choucha, W., Fossati, P., Rotge, J.
Open Accessindividual

A Randomized Add-on Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Bipolar Depression

This double-blind, placebo-controlled, randomised study (n=18) with those suffering from bipolar depression (BD; treatment-resistant) found that ketamine (35mg/70kg; 2x 2w apart) produced anti-depressant effects as measured on the MADRS scale. The effects were found immediately (40 minutes) and lasted up to three days.

Published
August 1, 2010
Journal
JAMA Psychiatry
Authors
Diazgranados, N., Ibrahim, L., Brutsche, N. E., Newberg, A., Kronstein, P., Khalife, S., Kammerer, W. A., Quezado, Z., Luckenbaugh, D. A., Salvadore, G., Machado- Vieira, R., Manji, H. K., Zarate, C. A.

Clinical Trials

25 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
Not yet recruitingPhase III

The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression

This randomised, double-blind, midazolam-controlled, multicentre trial (n=98) will investigate the efficacy and safety of low-dose subcutaneous ketamine in adults with bipolar depression.

Started
June 28, 2024
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
ACTRN12624000789561
RecruitingPhase III

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (INTENSIFY)

This randomized, controlled trial (n=1254) investigates the effect of an intensified pharmacological treatment (including ketamine/esketamine and clozapine) for schizophrenia, major depressive disorder (MDD), and bipolar depression in subjects who experienced a first-time treatment failure on their first-line treatment.

Started
March 31, 2024
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
NCT05603104
Active not recruitingPhase III

Predictors of Intravenous Ketamine Response in TRD

Randomized, double-blinded, midazolam-controlled crossover trial (n=40) testing single IV ketamine (0.5 mg/kg over 40 minutes) versus midazolam (30 µg/kg) in treatment-resistant depression to identify predictors of rapid and sustained response.

Started
January 19, 2024
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT05625555
CompletedPhase II

Ketamine for Treatment-Resistant Bipolar Disorder

Phase II, double-blind, randomized, quadruple-masked RCT (n=72) testing four IV ketamine infusions (0.5–0.75 mg/kg over 40 minutes) versus midazolam (0.02–0.03 mg/kg) as adjunctive treatment for moderate to severe treatment-resistant bipolar depression.

Started
April 30, 2022
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT05004896
CompletedPhase III

Ketamine as an Adjunctive Therapy for Major Depression (2) (KARMA-Dep2)

This parallel-group, randomised, quadruple-blind, controlled trial (n=104 planned; 63 actual) compares up to eight IV ketamine infusions (0.05 mg/kg) versus midazolam (0.045 mg/kg) in inpatients with major depressive episodes.

Started
September 13, 2021
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT04939649

Explore further

Search all Placebo papers Search all Bipolar Disorder trials Full Placebo profile Full Bipolar Disorder profile