Phase 4
Completed N=15
Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study
Source: ClinicalTrials.gov NCT01748955 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Percent Change in Contrast of Parameter Estimates (COPE) — 0.29; -2.12; -1.19; -1.33 Percentage change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study uses functional magnetic resonance imaging (fMRI) to investigate the effects of two different antidepressant medications (Paxil CR versus Wellbutrin XL) on reward processing in depressed patients who have attempted suicide or are currently experiencing suicidal thoughts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Contrast of Parameter Estimates (COPE) |
0.29; -2.12; -1.19; -1.33; -0.90; -0.87 | — |
| SECONDARY Change in Suicidal Ideation (SSI Score) |
11; 4.8; 3.3; 0.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patient suffering from an episode of major depressive disorder (MDD)
- Age range 18-65 years
- History of a past suicide attempt or score > 2 on HDRS item #3 (suicide) at in-person screening interview. Patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees with the plan to enroll the patient.
- Patients 60 years of age and older must score at least 25 on MMSE at screening.
- Patients 60 years of age and older must have a normal ECG within the past year.
Exclusion Criteria
- Bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; persons already taking SSRIs or bupropion for other indications (such as anxiety disorders).
- Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/ Social anxiety disorder, with secondary depression.
- Drug or alcohol dependence within past six months; persons with current drug or alcohol abuse may be enrolled if this is assessed as being of lesser importance than the major depressive episode.
- Blood pressure reading ≥ 140/90
- Active and/or unstable medical problems including a significant risk for seizures
- Antipsychotic medication required
- Patients who have become hypomanic or manic on antidepressants
- Contraindication to the use of an SSRI or bupropion, or currently using Zyban. Anorexia nervosa in remission at least one year is not an exclusion.
- Failure to respond to adequate trials of 3 SSRIs or paroxetine or bupropion in the last 2 years (failure to respond to therapeutic trial defined as: at least 2/3 maximal PDR dose for at least 6 weeks).
- Lacks capacity to consent
- Pregnancy, lactation, or plans to conceive during the course of study participation.
- Patients currently on effective treatment, who require adjunctive antipsychotic or mood stabilizing medication, or who are unlikely to respond to single agent treatment for depression will be excluded.
- Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded.
- Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.
Data sourced from ClinicalTrials.gov (NCT01748955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.