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Pioglitazone for bipolar mixed or depressive episode

Pioglitazone adjunct treatment for mixed or depressive episode in bipolar disorder: double blind randomized placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201211211556N46
Enrollment
50
Registered
2012-11-27
Start date
2012-12-31
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

Bipolar disorder.

Interventions

Intervention 1: Lithium with levels of 0.6 – 0.8 mEq/L + pioglitazone titrated to 30 mg/day for six weeks. Intervention 2: Lithium with levels of 0.6 – 0.8 mEq/L + placebo for six weeks.
Treatment - Drugs
Placebo
Lithium with levels of 0.6 – 0.8 mEq/L + pioglitazone titrated to 30 mg/day for six weeks
Lithium with levels of 0.6 – 0.8 mEq/L + placebo for six weeks

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: The patients who were diagnosed with depressive (Hamilton rating scale >=20) or mixed (both Hamilton >=20 and Mania>=18) based on DSM-IV-TR criteria will be included in the study after obtaining informed consent. Exclusion criteria 1. Disorders in other axes 2. Other psychotropic drugs 3. Taking antidepressants in the past month 4. Thyroid disorder 5. ECT in the previous two months 6. History of cardiovascular disorders 7. Pregnant or lactating women

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Reduction in depression. Timepoint: Week 6. Method of measurement: Hamilton Depression Rating Scale.

Secondary

MeasureTime frame
Reduction in depression. Timepoint: Week 2 and 4. Method of measurement: Hamilton Depression Rating Scale.;Reduction in mania. Timepoint: Weeks 2, 4 and 6. Method of measurement: Young Mania Rating Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

Tehran University of Medical Sciences

S.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

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