Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study
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|ClinicalTrials.gov Identifier: NCT01748955|
Recruitment Status : Completed
First Posted : December 13, 2012
Results First Posted : February 15, 2017
Last Update Posted : November 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression Suicidal Ideation||Drug: Paroxetine CR for Major Depressive Episode Drug: Bupropion XL for Major Depressive Episode||Phase 4|
Major depressive disorder (MDD) is a common and serious psychiatric illness. It is among the leading causes of disability and is the psychiatric disorder most often associated with suicide. The treatment of MDD with antidepressant medication remains largely trial and error. Little empirical evidence exists to guide the treatment of MDD when suicide risk is a major factor.
The study uses functional magnetic resonance imaging (fMRI) to compare the effects of paroxetine, an SSRI, versus bupropion, a non-SSRI, on brain activity in depressed patients with a past suicide attempt and/or current suicidal thoughts. Participants are randomly assigned to either paroxetine or bupropion treatment for 8 weeks, with fMRI scans involving a reward processing task at baseline and Week 8. Weekly study visits include interviews with a psychologist, self-report scales, and medication monitoring. All participants will then be offered 4 additional months of open clinical treatment. If original medication assignments prove to be ineffective, participants will have the option to switch to another medication. After completing the study, participants will be referred for ongoing treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||SSRI Versus Bupropion in High-Risk Major Depressive Disorder|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Active Comparator: Bupropion
Participants will receive bupropion XL for 8 weeks.
Drug: Bupropion XL for Major Depressive Episode
Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.
Other Name: Wellbutrin XL
Active Comparator: paroxetine CR
Participants will receive Paroxetine CR for 8 weeks.
Drug: Paroxetine CR for Major Depressive Episode
Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.
Other Name: Paxil CR
- Percent Change in Contrast of Parameter Estimates (COPE) [ Time Frame: Measured at Baseline (pre-treatment) and Week 8 (post-treatment) ]
% change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment COPE COPE is measured during Monetary Incentive Delay Task.
Task conditions are:
Reward= BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment= BOLD signal when subject loses 5cents vs. loses 0 cents
- Change in Suicidal Ideation (SSI Score) [ Time Frame: Measured at Baseline and Week 8 ]Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts
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): NCT01748955
|United States, New York|
|Columbia University/New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Michael F. Grunebaum, M.D.||Columbia University/NY State Psychiatric Institute|