Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223197
Status:
COMPLETED
Last Update Posted:
2012-04-03
First Post:
2005-09-14
Brief Title:
Pregnenolone Trial for Depression in Bipolar Disorders or Recurrent Major Depressive Disorder With Substance Abuse
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Double-blind Placebo Controlled Trial of Pregnenolone for Depression in Patients With Bipolar Disorders or Recurrent Major Depressive Disorder and a History of Substance Abuse
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 abusedependence 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 daysweek 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 capsuleday 50 mgd 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 eg 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 mgd 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 physicians knowledge and approval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None