Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression
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|ClinicalTrials.gov Identifier: NCT00429169|
Recruitment Status : Terminated (Interim analysis showed differential treatment effects.)
First Posted : January 31, 2007
Results First Posted : January 24, 2013
Last Update Posted : October 30, 2018
The primary study comparing effectiveness for suicidal ideation and/or behavior of two antidepressant medications in depressed patients who have attempted suicide or are currently experiencing suicidal thoughts has been completed.
A secondary study component using functional magnetic resonance imaging (fMRI) to investigate different medication effects on reward processing in the same sample is ongoing.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Paroxetine Drug: Bupropion||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. Selective serotonin reuptake inhibitors (SSRIs) are a type of antidepressant medication that works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. The study compared the effectiveness of paroxetine, an SSRI, versus bupropion, a non-SSRI, on suicidal ideation and/or behavior in depressed patients with a past suicide attempt and/or current suicidal thoughts. Results of the completed primary study have been published (Grunebaum MF et al. Neuropsychopharmacology. 2012 Feb;37(3):697-706).
In the ongoing secondary neuro-imaging component of the study, 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 :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Paroxetine Versus Bupropion for Suicide Ideators or Attempters With Major Depressive Disorder|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2013|
Active Comparator: Paroxetine
Participants will receive paroxetine for 8 weeks
Dosage will be 25 mg every day for 2 weeks, then 37.5 mg every day for 2 weeks, and then optional increase to 50 mg every day for the remainder of treatment.
Other Name: Paxil CR
Active Comparator: Bupropion
Participants will receive bupropion for 8 weeks
Dosage will be 150 mg every day for 2 weeks, then 300 mg every day for 2 weeks, and then optional increase to 450 mg every day for the remainder of treatment.
Other Name: Wellbutrin XL
- Go-No go Test [ Time Frame: Measured at Baseline and Week 8 ]Change in neuropsychological measure of impulsivity. Computer-based task involving induction of a dominant response tendency and testing of the subject's ability to withhold responding to less frequent non-target stimuli.
- Scale for Suicidal Ideation [ Time Frame: Baseline and Week 8 ]The clinician-rated Beck Scale for Suicidal Ideation (SSI) (Beck et al 1979)was used weekly for 8 weeks. It has 19 items scaled 0 (least severe) to 2 (most severe) and total score is the sum, ranging 0 to 38 (Beck et al 1979). Items measure frequency, intensity, and attitudes toward suicidal thoughts, feelings of control over them, and suicide plans. Mean score in 90 inpatients hospitalized for suicidal ideation was 9.4±8.4, versus 4.4±5.8 in outpatients as cited in the study by Beck et al, 1979.
- Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment [ Time Frame: Measured at Month 6 ]Suicide attempts, other suicidal behavior, or increase in suicidal thoughts that required a change in clinical treatment.
- Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task. [ Time Frame: Baseline and Week 8. ]
Comparison of fMRI results at baseline and after 8 weeks of antidepressant pharmacotherapy with paroxetine vs. bupropion.
Percent change in contrast of parameter estimates (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 5 cents vs. loses 0 cents
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): NCT00429169
|United States, New York|
|Columbia University/New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Michael F. Grunebaum, MD||Columbia University/New York State Psychiatric Institute|