Add-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders

Phase 4

Withdrawn

• Conditions: Depressive Illness
• Interventions: Drug: bupropion; Drug: citalopram

• Registration Number: NCT03278938
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

Depressed patients unremitted after monotherapy with citalopram or bupropion will remit following six weeks treatment with the combination of citalopram and bupropion.

Detailed Description

Participants in another study who did not remit during 12 weeks treatment with citalopram (to 40 mg/d) or bupropion (to 450 mg/d) will have citalopram (to 40 mg/d) or bupropion (to 450 mg/d) added for six weeks.

Study Timeline

• Study Start: 2012-06-29
• Study First Submitted: 2013-05-16
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• non-remission in Protocol #6559R
• age 18-66
• signs informed consent
• physically healthy

Exclusion Criteria

• bipolar disorder
• history of psychosis
• history of anorexia nervosa or bulimia
• history of seizure disorder, significant brain trauma or other medical reason to suspect increased seizure risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupropion added to citalopram	bupropion	patients who did not remit with citalopram will continue at the same dose and have bupropion added
citalopram added to bupropion	bupropion	Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added
citalopram added to bupropion	citalopram	Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added
bupropion added to citalopram	citalopram	patients who did not remit with citalopram will continue at the same dose and have bupropion added

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale	weeks 6	Decrease in score for Hamilton Rating Scale for Depression, 17-item version

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States