Back to resultsAdd-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders
Primary Purpose
Depressive Illness
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupropion
citalopram
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Illness focused on measuring depression, citalopram, bupropion, combination therapy
Eligibility Criteria
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bupropion added to citalopram
citalopram added to bupropion
Arm Description
patients who did not remit with citalopram will continue at the same dose and have bupropion added
Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added
Outcomes
Primary Outcome Measures
Hamilton Rating Scale
Decrease in score for Hamilton Rating Scale for Depression, 17-item version
Secondary Outcome Measures
Full Information
NCT ID
NCT03278938
First Posted
May 16, 2013
Last Updated
March 13, 2019
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT03278938
Brief Title
Add-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders
Official Title
Add-on to Cognitive, ERP and EEG Asymmetry in Affective Disorders (#6559R) [Formerly #5723]
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
PI Retired and no data was collected
Study Start Date
June 29, 2012 (Anticipated)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Illness
Keywords
depression, citalopram, bupropion, combination therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bupropion added to citalopram
Arm Type
Active Comparator
Arm Description
patients who did not remit with citalopram will continue at the same dose and have bupropion added
Arm Title
citalopram added to bupropion
Arm Type
Active Comparator
Arm Description
Patients who did not remit with bupropion will have bupropion continued at the same dose and citalopram will be added
Intervention Type
Drug
Intervention Name(s)
bupropion
Other Intervention Name(s)
Wellbutrin
Intervention Description
FDA approved drug for treating depression
Intervention Type
Drug
Intervention Name(s)
citalopram
Other Intervention Name(s)
Celexa
Intervention Description
FDA approved treatment for depression
Primary Outcome Measure Information:
Title
Hamilton Rating Scale
Description
Decrease in score for Hamilton Rating Scale for Depression, 17-item version
Time Frame
weeks 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W Stewart, MD
Organizational Affiliation
Research Psychiatrist II at New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.depression-nyc.org
Description
web site for the Depression Evaluation Service, New York State Psychiatric Institute
Learn more about this trial
Add-on to Cognitive, Event-Related Potentials (ERP) and Electroencephalogram (EEG) Asymmetry in Affective Disorders
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