Paroxetine/Bupropion in Suicide Attempters/Ideators With Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Suicide
Intervention: Paroxetine; Bupropion
Intervention description: 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.; 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.
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: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently suffering from a major depressive episode (unipolar only)

          -  History of a past suicide attempt or score greater than 2 on the Hamilton Depression
             Rating Scale (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.

          -  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:

          -  Any of the following conditions: 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; already taking selective serotonin reuptake inhibitors
             (SSRIs) or bupropion for other indications (such as anxiety disorders)

          -  Primary disorder is an anxiety disorder (e.g., panic disorder, general anxiety
             disorder, obsessive compulsive disorder, social anxiety disorder), with secondary
             depression

          -  Drug or alcohol dependence within 6 months prior to study entry (current drug or
             alcohol abuse may be permitted if study officials determine that the abuse is of
             lesser importance than the major depressive episode)

          -  Systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure
             greater than or equal to 90 mm Hg

          -  Significant active physical illness, particularly those that may affect the brain or
             serotonergic system (e.g., blood dyscrasias lymphomas, hypersplenism,
             endocrinopathies, kidney failure, severe chronic obstructive lung disease, autonomic
             neuropathies, active malignancy)

          -  Active medical problems

          -  Requires antipsychotic medication

          -  History of hypomania or mania while taking antidepressants

          -  Any condition that may make the use of an SSRI or bupropion medically inadvisable

          -  Currently using Zyban

          -  Failure to respond to adequate trials of three SSRIs, paroxetine, or bupropion within
             2 years prior to study entry (failure to respond to therapeutic trial defined as at
             least 2/3 maximal daily dose [PDR] for at least 6 weeks)

          -  Pregnant, breastfeeding, or plans to become pregnant during the course of study
             participation

          -  Currently on effective treatment, requires adjunctive antipsychotic or mood
             stabilizing medication, or is unlikely to respond to single agent treatment for
             depression

          -  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.