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Minocycline as an adjunctive therapy in patients with bipolar mania

Not Applicable
Conditions
Health Condition 1: G- Mental Health
Registration Number
CTRI/2021/12/038752
Lead Sponsor
Central Institute of Psychiatry
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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