Evaluation of the effect of Modafinil in the treatment of major depressive disorder

Comparison of therapeutic effects of modafinil plus sertraline versus sertraline plus placebo in outpatient treatment of major depressive disorder: a clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180522039784N1

Enrollment

Registered

2020-08-09

Start date

2019-09-23

Completion date

Unknown

Last updated

2020-09-07

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

Interventions

Intervention 1: Intervention group: receiving 200 mg of Modafinil each 12 hours plus standard dose of Sertraline for 6 weeks. Intervention 2: Control group: receiving placebo every 12 hours plus stand

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diagnosis of major depressive disorder Informed consent

Exclusion criteria

Exclusion criteria: Diagnosis of bipolar mood disorder, ADHD or any underlying medical disease Use of any illicit drugs Use of any medication that interferes modafinil action Past history of suicide Past history of receiving ECT Pregnancy Daily use of more than 250 mg of caffeine

Design outcomes

Primary

Measure	Time frame
Fatigue severity. Timepoint: Before intervention and 6 weeks after initiation. Method of measurement: Fatigue severity scale.;Mood cahnges. Timepoint: Before intervention and 6 weeks after initiation. Method of measurement: Beck's depression inventory.	—

Secondary

Measure	Time frame
Drug side effects. Timepoint: Six weeks after intervention. Method of measurement: Obtaining history.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Shabani

Karaj University of Medical Sciences

Pacino1373@yahoo.com+98 21 8846 7286

Outcome results

None listed

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