Trial intelligence / Profile preview

Wellbutrin XL Effects on SSRI-Induced Brain Reactivity

NCT00456820Phase 4

Key facts

Status: Completed
Start: Jul 2004
Countries: 1
Sponsor: Indiana University School of Medicine
Modality: Small Molecules

Drugs: bupropion
Conditions: sexual dysfunctionapathy

Overview

Phase 4, open-label, single-arm trial of bupropion in sexual dysfunction and apathy, sponsored by Indiana University School of Medicine. Primary endpoints: Activation and connectivity of frontal cortex and limbic region at 6 weeks, Apathy Evaluation Scale and 1 more. Started Jul 2004; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Wellbutrin XL Addition
Patients receive Wellbutrin XL added to their current SSRI regimen.

Who it enrols

Adults 18-60 with Major Depressive Episode treated with SSRIs (HDRS < 18) but experiencing apathy (AES < 10) or sexual dysfunction (CSFQ > 10). Excludes bipolar, schizophrenia, eating disorders, seizure history, and recent substance abuse.

Endpoints

Primary

Activation and connectivity of frontal cortex and limbic region6 weeks
Apathy Evaluation Scaleweekly for 6 weeks
Changes in Sexual Functioning Questionnaireweekly for 6 weeks

Secondary

Hamilton Depression Rating Scaleweekly for 6 weeks
Clinical Global Impression Severity and Improvement Scalesweekly for 6 weeks
Montgomery-Asberg Depression Rating Scale Item 8weekly for 6 weeks

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