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

NCT03278938 | Withdrawn Phase 4

• 1 other identifier: #5723
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Illness

Keywords

depression; citalopram; bupropion; combination therapy

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale

  Decrease in score for Hamilton Rating Scale for Depression, 17-item version

  weeks 6

Study Arms (2)

bupropion added to citalopram

ACTIVE COMPARATOR

patients who did not remit with citalopram will continue at the same dose and have bupropion added

Drug: bupropion; Drug: citalopram

citalopram added to bupropion

ACTIVE COMPARATOR

Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added

Drug: bupropion; Drug: citalopram

Interventions

bupropion DRUG

FDA approved drug for treating depression

Also known as: Wellbutrin

bupropion added to citalopram; citalopram added to bupropion

citalopram DRUG

FDA approved treatment for depression

Also known as: Celexa

bupropion added to citalopram; citalopram added to bupropion

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

• web site for the Depression Evaluation Service, New York State Psychiatric Institute

MeSH Terms

Conditions

Depression

Interventions

Bupropion; Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jonathan W Stewart, MD

  Research Psychiatrist II at New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: treatment in this study was determined by treatment received in prior study; i.e., those who had received escitalopram then receive escitalopram + bupropion; those initially taking bupropion then receive escitalopram + bupropion

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: September 12, 2017
• Study Start: June 29, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

US (1)