Efficacy of adjunctive topiramate in acute mania

Phase 2

• Conditions: Condition 1: bipolar I disorder most recent manic episode. Condition 2: bipolar I disorder most recent manic episode.; Moderate depressive episode; Severe depressive episode without psychotic symptoms

• Registration Number: IRCT201110317960N1
• Lead Sponsor: niversity of social welfare and rehabilitation sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1) age 18 and over; 2) bipolar I disorder most recent manic episode (according to DSMIV-TR criteria). Exclusion criteria: 1) pregnant woman; 2) lactating woman; 3) presence of disabling medical or neurologic disease; 4) history of kidney disease; 5) history of renal stone; 6) history of hypersensitivity to topiramate.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of adjunctive topiramate in acute mania. Timepoint: after 8 weeks. Method of measurement: YMRS.

Secondary Outcome Measures

Name	Time	Method
Appetite. Timepoint: after 8 weeks. Method of measurement: interview.;Weight. Timepoint: after 8 weeks. Method of measurement: according to weight.;Side effects of topiramate. Timepoint: after 8 weeks. Method of measurement: interview.;Suicidal ideas. Timepoint: after 8 weeks. Method of measurement: interview.;Compliance. Timepoint: after 8 weeks. Method of measurement: interview and nursing records.;Lithium toxicity. Timepoint: after 8 weeks. Method of measurement: interview and physical examination.