Efficacy of adjunctive topiramate in acute mania

Comparison of efficacy of lithium and topiramate with lithium and placebo in patients with bipolar I disorder most recent manic episode

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201110317960N1

Enrollment

Registered

2011-12-09

Start date

2011-07-30

Completion date

Unknown

Last updated

2018-02-22

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

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

Interventions

Intervention 1: In intervention group patients would receive 900mg/day of lithium carbonate and 2mg/day of risperidone (may be increased if needed to 8mg/day) or equivalent dose of other antipsychotic

Treatment - Drugs

In intervention group patients would receive 900mg/day of lithium carbonate and 2mg/day of risperidone (may be increased if needed to 8mg/day) or equivalent dose of other antipsychotics plus topiramat

In control group patients would receive 900mg/day of lithium carbonate and 2mg/day of risperidone (may be increased if needed to 8mg/day) or equivalent dose of other antipsychotics plus placebo.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Mirsepassi

University ofsocial welfarw and rehabilitation sciences

za.mirsepassi@uswr.ac.ir ,zahesbanoo@yahoo.com , drzmirsepassi@yahoo.com+98 21 8808 2585

Outcome results

None listed

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