Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-05-31

Brief Summary

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This study will test the therapeutic potential of augmenting a stable SSRI regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients diagnosed with PTSD.

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Detailed Description

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See brief summary

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Pregnenolone

Group Type ACTIVE_COMPARATOR

Pregnenolone or Placebo

Intervention Type DRUG

Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID

2

Placebo

Group Type PLACEBO_COMPARATOR

Pregnenolone or Placebo

Intervention Type DRUG

Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID

Interventions

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Pregnenolone or Placebo

Pregnenolone 50 mg BID, Pregnenolone 150 mg BID, Pregnenolone 250 mg BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 18-65 years of age, any ethnic group, either sex
2. DSM-IV diagnosis of PTSD by MINI (see schedule of events)
3. No change in SSRI medications for \> 4 weeks.
4. No anticipated need to alter any psychotropic medications for the 10-week duration of the study.
5. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion Criteria

1. Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
2. Use of oral contraceptives or other hormonal supplementation such as estrogen.
3. Significant suicidal or homicidal ideation.
4. Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
5. Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition; history of substance dependence within the last 3 months
6. Female patients who are pregnant or breast-feeding.
7. Known allergy to study medication.
8. Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc.) will be excluded, as suggested by the FDA; patients taking these agents will not be eligible for this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No