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

NCT ID: NCT03278938

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-29

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Depressive Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bupropion added to citalopram

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

Group Type ACTIVE_COMPARATOR

bupropion

Intervention Type DRUG

FDA approved drug for treating depression

citalopram

Intervention Type DRUG

FDA approved treatment for depression

citalopram added to bupropion

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

Group Type ACTIVE_COMPARATOR

bupropion

Intervention Type DRUG

FDA approved drug for treating depression

citalopram

Intervention Type DRUG

FDA approved treatment for depression

Interventions

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bupropion

FDA approved drug for treating depression

Intervention Type DRUG

citalopram

FDA approved treatment for depression

Intervention Type DRUG

Other Intervention Names

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Wellbutrin Celexa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan W Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

Research Psychiatrist II at New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.depression-nyc.org

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

Other Identifiers

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#5723

Identifier Type: -

Identifier Source: org_study_id

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