A Phase 4 interventional study of Paroxetine and Bupropion in Depression, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-30.
Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 101 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive paroxetine for 8 weeks
Drug: Paroxetine
Participants will receive bupropion for 8 weeks
Drug: Bupropion
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.
Also known as: Paxil CR
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.
Also known as: Wellbutrin XL
Go-No go Test
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.
Time frame: Measured at Baseline and Week 8
Scale for Suicidal Ideation
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.
Time frame: Baseline and Week 8
Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment
Suicide attempts, other suicidal behavior, or increase in suicidal thoughts that required a change in clinical treatment.
Time frame: Measured at Month 6
Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task.
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
Time frame: Baseline and Week 8.
Recruitment dates were 2/2005-7/2009 with follow-up completed in January 2010.
| Milestone | Paroxetine | Bupropion |
|---|---|---|
| Started | 38 | 40 |
| Completed | 36 | 38 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Ineligibility discovered after entry | 2 | 1 |
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.
| Commission errors | Paroxetine | Bupropion |
|---|---|---|
| Go-No go Test | -0.09 ± 0.8 | -0.06 ± 0.89 |
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.
| Points on Scale for Suicidal Ideation | Paroxetine | Bupropion |
|---|---|---|
| Baseline | 8.0 ± 6.7 | 9.9 ± 7.4 |
| Week 8 | 2.3 ± 4.5 | 4.7 ± 6.6 |
Suicide attempts, other suicidal behavior, or increase in suicidal thoughts that required a change in clinical treatment.
| Events | Paroxetine | Bupropion |
|---|---|---|
| Occurrence of Suicidal Ideation or Acts Necessitating a Change in Treatment | 4 | 6 |
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
| percentage of change in COPE | Paroxetine | Bupropion |
|---|---|---|
| Brain Activity Measured by BOLD Signal With fMRI During a Reward Processing Task. | -0.27 (-0.59 to 2.9) | -0.95 (-1.3 to 1.7) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paroxetine | — | 3/36 (8.3%) | 0/36 (0%) |
| Bupropion | — | 2/38 (5.3%) | 0/38 (0%) |
| Event | Paroxetine | Bupropion |
|---|---|---|
| Increased suicidal thoughts causing admission to hospitalNervous system disorders | 2/36 | 2/38 |
| Suicide attempt by acetaminophen overdoseHepatobiliary disorders | 1/36 | 0/38 |
| Age, Categorical(Participants) | Paroxetine | Bupropion | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 36 | 38 | 74 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Paroxetine | Bupropion | Total |
|---|---|---|---|
| Mean | 35.2 ± 12.8 | 37.9 ± 11.9 | 36.4 ± 12.7 |
| Sex: Female, Male(Participants) | Paroxetine | Bupropion | Total |
|---|---|---|---|
| Female | 21 | 21 | 42 |
| Male | 15 | 17 | 32 |
| Region of Enrollment(participants) | Paroxetine | Bupropion | Total |
|---|---|---|---|
| United States | 36 | 38 | 74 |
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New York State Psychiatric Institute