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

March 13, 2019 updated by: New York State Psychiatric Institute

Add-on to Cognitive, ERP and EEG Asymmetry in Affective Disorders (#6559R) [Formerly #5723]

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bupropion added to citalopram
patients who did not remit with citalopram will continue at the same dose and have bupropion added
Drug: bupropion
FDA approved drug for treating depression
Other Names:
  • Wellbutrin
Drug: citalopram
FDA approved treatment for depression
Other Names:
  • Celexa
Active Comparator: citalopram added to bupropion
Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added
Drug: bupropion
FDA approved drug for treating depression
Other Names:
  • Wellbutrin
Drug: citalopram
FDA approved treatment for depression
Other Names:
  • Celexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale
Time Frame: weeks 6
Decrease in score for Hamilton Rating Scale for Depression, 17-item version
weeks 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Investigators

  • Principal Investigator: Jonathan W Stewart, MD, Research Psychiatrist II at New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 29, 2012

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #5723

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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