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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278938
Recruitment Status : Withdrawn (PI Retired and no data was collected)
First Posted : September 12, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Illness Drug: bupropion Drug: citalopram Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Add-on to Cognitive, ERP and EEG Asymmetry in Affective Disorders (#6559R) [Formerly #5723]
Estimated Study Start Date : June 29, 2012
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016


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 Name: Wellbutrin

Drug: citalopram
FDA approved treatment for depression
Other Name: 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 Name: Wellbutrin

Drug: citalopram
FDA approved treatment for depression
Other Name: Celexa




Primary Outcome Measures :
  1. Hamilton Rating Scale [ Time Frame: weeks 6 ]
    Decrease in score for Hamilton Rating Scale for Depression, 17-item version



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278938


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Jonathan W Stewart, MD Research Psychiatrist II at New York State Psychiatric Institute
Additional Information:
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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03278938    
Other Study ID Numbers: #5723
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Keywords provided by New York State Psychiatric Institute:
depression
citalopram
bupropion
combination therapy
Additional relevant MeSH terms:
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Mood Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Bupropion
Citalopram
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Uptake Inhibitors
Serotonin Agents