Placebo for Bipolar Disorder

1 paper and 24 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

1 paper

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: Brutsche, N. E., Diazgranados, N., Ibrahim, L., Kammerer, W. A., Khalife, S., Kronstein, P., Luckenbaugh, D. A., Machado-Vieira, R., Manji, H., Newberg, A. B., Quezado, Z., Salvadore, G., Zarate, C. A.

Clinical Trials

24 trials

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

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

Temporarily not availablePhase IV

IM Ketamine vs Midazolam for Suicidal ER Patients

We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.

Started: January 2, 2021
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT04640636

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