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Efficacy and Safety of Ketamine Treatment in the Depressive Phase of Bipolar Disorder and Exploration of Metabolites Involved in its Efficacy: A Placebo-Controlled, Double-Blind, Randomized and Extended, Open-Label Trial

Ketamine Treatment in Bipolar Disorder

Sakurai Hitoshi

Kyorin University Hospital

6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan

hitoshi-sakurai@ks.kyorin-u.ac.jp

Sakurai Hitoshi

Kyorin University Hospital

6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan

+81-422-47-5511

hitoshi-sakurai@ks.kyorin-u.ac.jp

Recruiting

Oct. 11, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Outpatients who meet the criteria for a current depressive episode of bipolar disorder in the International Classification of Diseases, 10th Edition (ICD-10)
2. Male or female between 18 and 64 years old at the time of enrollment
3. Current depressive episode lasting at least 1 month
4. A total MADRS score of 20 or higher on the assessment at screening
5. Patients with a score of 70% or higher on the MacCAT assessment of understanding (10 points total), awareness (6 points total), expressed choice (8 points total), and final choice (2 points total), indicating that the patient has sufficient capacity to make a decision on consent.
6. Cases in which written consent for participation in the research has been obtained from the research participant himself/herself.

1. Having previously received injections of esketamine or ketamine for the treatment of depression
2. Having had a change in antidepressants, antipsychotics, lithium carbonate, or mood stabilizers taken within 1 week prior to enrollment
3. Having received electroconvulsive therapy within 3 months prior to enrollment
4. Substance-related disorder (excluding nicotine and caffeine) within 6 months prior to enrollment
5. Positive urine screening for dependent substances (except for those positive for drugs taken for treatment)
6. Pregnant, lactating or intending to become pregnant
7. History of hypersensitivity to ketamine
8. History of epilepsy or convulsive seizures
9. Hypertension (systolic pressure >160 mmHg, diastolic pressure >100 mmHg)
10. Acute cerebrovascular accident within 3 months prior to enrollment
11. Cerebral hypertension within 3 months prior to enrollment
12. Severe cardiac decompensation failure within 3 months prior to enrollment
13. Any of the following laboratory abnormalities at the time of enrollment
- Serum creatinine > 1.5 mg/dl
- AST 150 IU/L or more
- ALT 150 IU/L or higher 14.
14. Participation in any other clinical trial or clinical study within 3 months prior to enrollment (limited to those with invasive or interventional procedures)
15. Imminent suicidal ideation at the time of enrollment
16. Judged by the principal investigator or others to be inappropriate as a research subject

Both

Depressive phase of bipolar disorder

Placebo-controlled, double-blind, randomized, controlled study
Ketamine: Intravenous administration of ketamine hydrochloride (0.5 mg/kg) plus saline solution (total amount 50 mL) will be performed over 40 minutes twice a week, four administrations in total.
Saline: 50 mL of saline will be administered intravenously over 40 minutes twice a week for a total of 4 times.

Extended single-arm open-label study
Ketamine: Intravenous administration of ketamine hydrochloride (0.5 mg/kg) plus saline solution (total amount 50 mL) will be performed over 40 minutes twice a week, four administrations in total.

Severity of depressive symptoms as assessed using the Montgomery-Asberg Depression Rating Scale

Severity of depressive symptoms as assessed by the Quick Inventory of Depressive Symptoms - Self-Report
Severity of manic symptoms as assessed by the Young Mania Rating Scale and Mood Disorder Questionnaire
Severity of suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale
Quality of life assessed using the EuroQol 5 dimensions 5-level
Adverse events as assessed by dvalg for the Kliniske Undersogelser side effect rating scale
Mystical experience as assessed by the Japanese version of the 30-item Mystical Experience Questionnaire
Challenging experience as assessed by the Japanese version of the Challenging Experience Questionnaire
Ego-dissolution as assessed by the Japanese version of the Ego-Dissolution Inventory

+81-42-341-2712-7828

Sept. 20, 2024

No

none