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Minocycline as an adjunctive therapy in patients with bipolar mania

Minocycline as an adjunctive therapy in patients with bipolar mania: A randomized double blind placebo controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038752
Enrollment
40
Registered
2021-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G- Mental Health

Interventions

Intervention1: Adjunctive Minocycline Therapy: Tablet minocycline 100 mg BD orally for 6 weeks in patients with Bipolar mania along with usual treatment Control Intervention1: Placebo: Tablet Placebo

Sponsors

Central Institute of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for group 1 (Minocycline) and Group 2 (Placebo) 1. Male inpatients satisfying the ICD 10-DCR[1993] criteria of Bipolar affective disorder, current episode mania with YMRS score of >20. 2.Age group of 18-50 years. 3.Drug naive or drug free patients for minimum 2 weeks for mood stabilisers/antipsychotics and 4 weeks for depot antipsychotics. 4. Those who give informed consent for participating in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria for group 1 (Minocycline) and Group 2 (Placebo) 1. Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine. 2. Significant current/ past medical or neurological illness including severe hepatic disease and history of severe head injury . 3. Known hypersensitivity to Tab. Minocycline or any of its components. 4. Patients who had received ECT in last 6 months.

Design outcomes

Primary

MeasureTime frame
Effectiveness of Tab. Minocycline (200mg/day) as an adjunctive therapy assessed by YMRS BPRS and CGI scores in patients with bipolar mania.Timepoint: Baseline, 2 weeks and 6 weeks—

Secondary

MeasureTime frame
Change in the levels of IL-1β-converting enzyme, iNOS,and Bcl-2 in patients receiving adjunctive Tab. Minocycline (200 mg/day).Timepoint: Baseline, 2 weeks and 6 weeks—

Countries

India

Contacts

Public ContactRoshan V Khanande

Central Institute of Psychiatry

roshankhanande@gmail.com7070896004

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026