A study to compare the effect and safety of adding pioglitazone to standard treatment in patients with depression.

A comparative study on efficacy and safety of pioglitazone as add on therapy with standard therapy in patients with depression - A randomized open labelled prospective study. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092567

Enrollment

Registered

2025-08-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: Tablet Pioglitazone: Tablet Pioglitazone 15 mg OD for first 2 weeks then 15 mg BD for 10 weeks as an add on therapy to standard therapy(Citalopram 10 mg) Control Intervention1: Standard

Eligibility

Inclusion criteria

Inclusion criteria: Patients with mild to moderate depression diagnosed by DSM 5 criteria with Hamilton Depression score 10-17.Patients with unresolved symptoms of depression with standard dose of antidepressant

Exclusion criteria

Exclusion criteria: Patients with severe depression Electroconvulsive therapy within 6 months Patients with substance abuse Pregnant and lactating mothers Patients with liver disease, heart failure, renal impairment

Design outcomes

Primary

Measure	Time frame
Improvement in Hamilton depression scores in study groupTimepoint: Baseline, 4 weeks, 8 weeks, 12 weeks.	—

Secondary

Measure	Time frame
Any adverse drug event due to Tablet Pioglitazone and Tablet CitalopramTimepoint: At every visit patient will be assessed for any adverse drug reactions with additional 1 month follow up	—

Countries

India

Contacts

Public ContactDr Aruna T

Government Kilpauk Medical college

arunabala511@gmail.com9444276923

Outcome results

None listed

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