Modafinil and treatment of major depression

A clinical trial of adjunctive Modafinil treatment in patients with major depression: a double blind and placebo controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138902301556N15

Enrollment

Registered

2010-05-24

Start date

2010-06-05

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. Depressive episode

Interventions

Intervention 1: Capsule Fluoxetine 40 mg/day plus Capsule Modafinil (400 mg/day) as intervention group for 6 weeks. Intervention 2: Cap fluoxetine 40 mg/day plus Cap. placebo as control group for 6 we

Treatment - Drugs

Placebo

Capsule Fluoxetine 40 mg/day plus Capsule Modafinil (400 mg/day) as intervention group for 6 weeks

Cap fluoxetine 40 mg/day plus Cap. placebo as control group for 6 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Presence of Major Depressive Disorder based on DSM-IV criteria, Baseline Hamilton Depression Rating Scale (HAM-D) (17-item) score of at least 22,age between 18 to 50 years old . Exclusion criteria: Presence of Psychosis, any diagnosis in Axis I and II, Receiving psychotropic medications, receiving any antidepressants during past one month or ECT in past two months, Presence of hypothyroidism or cardiovascular problems, nursing or pregnant women

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of depression. Timepoint: Baseline and weeks 2,4 and 6. Method of measurement: Hamiltion Depression Rating Scale 17-Item.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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