Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Paroxetine Versus Bupropion for Suicide Ideators or Attempters With Major Depressive Disorder|
- Go-No go Test [ Time Frame: Measured at Baseline and Week 8 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: No ]Comparison of fMRI results at baseline and after 8 weeks of antidepressant pharmacotherapy with paroxetine vs. bupropion.
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||January 2013|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429169
|United States, New York|
|Columbia University/New York State Psychiatric Institute|
|New York City, New York, United States, 10032|
|Principal Investigator:||Michael F. Grunebaum, MD||Columbia University/New York State Psychiatric Institute|