Efficacy of Donepezil in the treatment of Major Depressive Disorder

Evaluating the efficacy of adding Donepezil to a selective serotonin re-uptake inhibitor (Sertraline) in the treatment of major depressive disorder

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013031011885N2

Enrollment

Registered

2014-12-01

Start date

2014-07-10

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

Major Depressive Disorder. Sever Depressive Episode Without Psychotic Symptoms

Interventions

Intervention 1: Intervention group: Twenty patients receive donepezil tablet 5 miligram/daily plus sertraline tablet 50 -100 miligram/day given orally up to three months. Intervention 2: Control gro

Treatment - Drugs

Placebo

Intervention group: Twenty patients receive donepezil tablet 5 miligram/daily plus sertraline tablet 50 -100 miligram/day given orally up to three months.

Control group: Twety patients receive placebo .It is made similar to donepezil tablet by pharmaceutical industry experts.The placebo is added to sertraline. It is given orally up to three months .

Eligibility

Sex/Gender

All

Age

25 Years to 55 Years

Inclusion criteria

Inclusion criteria: Entry: All outpatients with Major Depressive Disorder based on DSM-IV-TR in the age range of 25-55 year old who refer to psychiatric clinic in Zare hospital or Tooba clinic. Exclusion criteria: Catatonia; Acute suicidal idea; Major past medical history; Endocrine diseases; Chronic cardiovascular diseases; Respiratory diseases; Hepatic failure; Renal failure; Active peptic ulcer, Acute infectious diseases; Malignancies; Neurolgic disorders; Axis I psychiatric disorders except of Major depressive disorder; Axis II psychiatric disorders; Family history of bipolar disorder; Concomitant use of psychiatric drugs except for Antidepressants; Outside the age range of 25-55; refuse to participate in the study; Pregnancy, Breastfeeding; Lack of contraception in women of childbearing age.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Memory. Timepoint: Before intervention,End of intervention,3months after ending intervention. Method of measurement: With wechsler memory scale.;Depression. Timepoint: Before intervention,Every month for three months after beginning intervention,3months after ending intervention. Method of measurement: With hamilton depression rating scale.	—

Secondary

Measure	Time frame
Side effects of drugs. Timepoint: 1st,2st.3st month after intervention and three month after ending intervention. Method of measurement: By filling a checklist of drug side effects.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Seid Davood Hosseini Talari

Mazandaran University of Medical Sciences

hosseni1497@yahoo.com+98 11 3311 7746

Outcome results

None listed

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