Trial intelligence / Profile preview

Modafinil for Atypical Depression

NCT00215176Phase 3

Key facts

Status: Completed
Start: Feb 2003
Sponsor: Duke University
Modality: Small Molecules

Drugs: modafinil
Conditions: atypical depression

Overview

Phase 3, randomised, double-blind trial in atypical depression comparing Modafinil Maintenance with Placebo (2 arms). Primary endpoint: Hamilton Depression 29-Item Scale with Atypical Features at 24 weeks. Started Feb 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Modafinil Maintenance
Continued treatment with Modafinil.
Placebo
Switched to matching Placebo.

Who it enrols

Adults 18-65 with atypical depression (DSM-IV), HAM-D-29 score >= 18, and CGI-S >= 4. Excludes bipolar, schizophrenia, substance abuse, suicide risk, and non-response to 3 prior adequate antidepressant trials.

Endpoints

Primary

Hamilton Depression 29-Item Scale with Atypical Features24 weeks

Secondary

Atypical Depression Diagnostic Scale24 weeks
Clinical Global Impressions Severity24 weeks
Clinical Global Impressions Improvement24 weeks
Symptom Checklist 9024 weeks
Epworth Sleepiness Scale24 weeks
Brief Fatigue Inventory24 weeks
Fatigue Severity Scale24 weeks
Severity of Symptoms Scale24 weeks

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