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Evaluation of the Efficacy of Piracetam plus Sertraline in Patients with Depression

Efficacy of Piracetam Augmentation of Sertraline in Treatment of Drug-naïve Patients with Major Depressive Disorder: A Double-Blind, Placebo-Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100119003106N37
Enrollment
30
Registered
2018-03-11
Start date
2017-09-23
Completion date
Unknown
Last updated
2018-03-26

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

Conditions

Major Depressive Disorder. Major depressive disorder, single episode, unspecified

Interventions

Intervention 1: Intervention group: Piracetam 800 mg tablets manufactured by Darou Pakhsh Pharmaceutical Company. One pill should be taken every 8 hours a day for 2 months. Pills should be swallowed c

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients experiencing first episodes of depression according to DSM-V criteria whose Hamilton's Depression Rating Scale scores were ranged from 18 to 36. Being drug-naïve to antidepressant treatments.

Exclusion criteria

Exclusion criteria: History of being on antidepressant medication. History of having psychiatric disorders. Having significant suicidal ideation. Suffering from liver and kidney dysfunction and cardiovascular disorders. History of drug abuse. Pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Severity of Depression in the patients. Timepoint: Before the intervention and 4 and 8 weeks after initiation of the intervention. Method of measurement: Hamilton's Depression Rating Scale (HDRS).;Serum levels of Interleukin_6. Timepoint: Before the intervention and 4 and 8 weeks after initiation of the intervention. Method of measurement: Enzyme_Linked Immunosorbent Assay (ELISA) test for Interleukin_6.

Secondary

MeasureTime frame
Quality of life. Timepoint: At the baseline, and 4 and 8 weeks following the interventions. Method of measurement: Questionnaire.;Possible side effects will be investigated as secondary outcome measures. Timepoint: At the baseline, and 4 and 8 weeks following the interventions. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyede Alaleh Hosseini

Islamic Azad University

hoseini.alaleh@yahoo.com+98 21 2264 0051

Outcome results

None listed

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