Paroxetine/Bupropion in Depression With Suicide Attempt or Thoughts: fMRI Study
Condition: Depression; Suicidal Ideation
MeSH terms: Depression; Depressive Disorder; Suicidal Ideation
Intervention: Paroxetine CR for Major Depressive Episode; Bupropion XL for Major Depressive Episode
Intervention description: 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.; 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.
Intervention MeSH terms: Bupropion; Paroxetine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Reward; BOLD signal; Suicide

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient suffering from an episode of major depressive disorder (MDD)

          2. Age range 18-65 years

          3. 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.

          4. Patients 60 years of age and older must score at least 25 on MMSE at screening.

          5. Patients 60 years of age and older must have a normal ECG within the past year.

        Exclusion Criteria:

          1. 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).

          2. Primary disorder is an anxiety disorder such as Panic disorder/GAD/OCD/ Social anxiety
             disorder, with secondary depression.

          3. 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.

          4. Blood pressure reading ≥ 140/90

          5. Active and/or unstable medical problems including a significant risk for seizures

          6. Antipsychotic medication required

          7. Patients who have become hypomanic or manic on antidepressants

          8. 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.

          9. 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).

         10. Lacks capacity to consent

         11. Pregnancy, lactation, or plans to conceive during the course of study participation.

         12. 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.

         13. Patients with ferrous metal implants in their bodies, or a history of claustrophobia
             that precludes MRI, will be excluded.

         14. Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of
             treatment.