Esketamine for Bipolar Disorder

2 papers and 6 clinical trials exploring esketamine as a treatment for bipolar disorder.

Compounddissociative

Esketamine

Esketamine (Spravato) is the S-enantiomer of ketamine, approved as an intranasal treatment for treatment-resistant depression and MDD with acute suicidal ideation. It is administered under clinical supervision with post-dose monitoring and has reached over $1.6 billion in annual sales.

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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.

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Academic Research

2 papers

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Efficacy and Safety of Subcutaneous Esketamine in the Treatment of Suicidality in Major Depressive Disorder and Bipolar Depression

This open-label study (n=70) on suicidal ideation (SI) in patients with major depressive disorder (MDD) and bipolar depression (BD) finds that esketamine (1x p/w 6ws) led to significant reductions in SI at the end of the study (24h after last administration). There was no statistically significant difference between the two subpopulations.

Published: August 31, 2022
Journal: Clinical Drug Investigation
Authors: Abdo, G. L., Barbosa, M. G., De Oliveira Cerqueira, R., Del Porto, J. A., Del Sant, L. C., Delfino, S. R., Fava, V. A. R., Grossi, J. D., Lacerda, A. L. T., Lucchese, C., Magalhães, E., Nakahira, C., Sarin, L. M., Steglich, M., Surjan, J., Tuena, M. A.

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Comparative efficacy of racemic ketamine and esketamine for depression: A systematic review and meta-analysis

This systemic review and meta-analysis (2020) of 24 clinical trials (n=1877) assessed the comparative efficacy and tolerability of racemic and esketamine for the treatment of unipolar and bipolar major depression. The authors found that intravenous ketamine appeared to be more efficacious than intranasal esketamine for the treatment of depression.

Published: January 1, 2021
Journal: Journal of Affective Disorders
Authors: Bahji, A., Vazquez, G. H., Zarate, C. A.

Clinical Trials

6 trials

Enrolling by invitationPhase NA

Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions

This observational cohort study (n=200) will assess whether a speech-based machine learning algorithm can predict treatment response to psychiatric interventions, specifically repetitive transcranial magnetic stimulation (TMS) and Spravato (esketamine) nasal spray.

Started: February 1, 2025
Type: observational
Randomized: No
Registry ID: NCT06823024

TerminatedPhase NA

Behavioural Activation Therapy and Esketamine for Resistant Depression

Randomised, parallel-arm trial (n=6 actual) comparing concurrent behavioural activation therapy plus intranasal esketamine versus esketamine alone for treatment-resistant depressive episodes in MDD or BD.

Started: June 1, 2024
Type: interventional
Blinding: single
Randomized: Yes
Registry ID: NCT06431386

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 NA

University of Iowa Interventional Psychiatry Service Patient Registry

Prospective observational registry (n=1000) collecting biomarker and clinical outcome data from patients receiving ECT, TMS/dTMS, racemic ketamine infusions, or intranasal esketamine for treatment‑resistant depression and OCD.

Started: November 2, 2020
Type: observational
Blinding: none
Randomized: No
Registry ID: NCT04480918

Unknown statusPhase NA

The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT)

Randomised, quadruple-blind, factorial trial (n=150) comparing S-ketamine 0.25 mg/kg and ketamine 0.5 mg/kg versus propofol+saline during ECT in adults with depressive disorders to evaluate short-term efficacy and safety.

Started: August 1, 2020
Type: interventional
Blinding: quadruple
Randomized: Yes
Registry ID: NCT04399070

CompletedPhase II

A multicentre, double-blind, randomised, placebo - controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subjects with treatment-resistant bipolar depression

Double-blind, randomised, placebo-controlled Phase II trial (n=88) in Poland testing inhaled esketamine (inhalation powder) versus placebo in adults 18–65 with treatment-resistant bipolar depression to assess efficacy, safety and pharmacokinetics.

Started: July 30, 2018
Type: interventional
Blinding: double
Randomized: Yes
Registry ID: 2018-002669-20

Explore further

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