Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse
Condition: Bipolar Disorder; Major Depressive Disorder; Substance Abuse
MeSH terms: Recurrence; Substance-Related Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to determine if pregnenolone supplement is associated with a
      reduction in substance use and craving in patients with recurrent major depressive disorder
      or bipolar disorder and substance abuse/dependence. This research also wants to explore if
      pregnenolone supplements are associated with improvement in psychiatric symptoms and memory,
      which are often negatively affected in these patients. It is hypothesized that patients
      receiving pregnenolone supplements would show greater improvements in mood symptoms and
      memory, and crave substances less than the patients receiving placebo.
    

Detailed description: 
      Seventy five - (75) outpatients meeting the inclusion and exclusion criteria will be enrolled
      after completing an IRB-approved informed consent process. Baseline evaluation will include a
      medical and psychiatric history, structured clinical interview for DSM-IV (SCID), mood
      assessment with the Hamilton Rating Scale for Depression (HRSD, 17-item version), Inventory
      of Depressive Symptomatology-Self Report (IDS-SR) (Rush et al., 1996), Hamilton Rating Scale
      for Anxiety (HRSA), Young Mania Rating Scale (YMRS), and, and cognitive assessment with the
      Rey Auditory Verbal Learning Test (RAVLT), Stroop Test Color Trails, Wechsler Test of Adult
      Reading and the Brief Visual Memory Test-Revised (BVMT-R) will be performed. Substance use
      (days/week) of use, urine drug screens and time to relapse will be monitored. Craving for
      substances will be monitored with visual analogue scales. Pregnenolone or placebo will be
      initiated at one capsule/day (50 mg/d if active medication). Pregnenolone and the placebo
      will be obtained from Abrams Pharmacy, which has ensured the potency (the supplier uses GMP
      pharmaceutical standards). Participants will return for reassessment every 2 weeks for 8
      weeks with the HRSD, IDS-SR, YMRS, ISS, and a neurocognitive battery (e.g. RAVLT, Stroop Test
      and Trails B). Side effects will be monitored with the PRD-III Somatic Symptom Scale (Thase
      et al., 1996). At week 4 subjects who not having significant side effects and have not had a
      50% reduction in HRSD scores will have the dosage increased to two capsules per day (100 mg/d
      if active medication). Participants will be paid $30 at weeks 2, 4, and 8. Participants who
      respond favorably will, at completion, have the option of continuing this over-the-counter
      supplement if they so choose with their physician's knowledge and approval.
    

Intervention name(s): Pregnenolone
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar with depression; Recurrent major depressive disorder; substance abuse dependence