Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs

NCT00560781 | Completed

• 1 other identifier: VA IRB# 01023
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; Pregnenolone; Cognition

Outcome Measures

Primary Outcomes (1)

• CAPS, BAC-A

  Prospective

Secondary Outcomes (1)

• PCL, CD-RISC, CGI, BDI-II

  Prospective

Study Arms (2)

1

ACTIVE COMPARATOR

Pregnenolone

Drug: Pregnenolone or Placebo

2

PLACEBO COMPARATOR

Placebo

Drug: Pregnenolone or Placebo

Interventions

Pregnenolone or Placebo DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
• Use of oral contraceptives or other hormonal supplementation such as estrogen.
• Significant suicidal or homicidal ideation.
• 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
• Female patients who are pregnant or breast-feeding.
• Known allergy to study medication.
• 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.

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Durham VAMC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Christine E Marx, MD MA

  Durham VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: April 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

US (1)