NCT00174889

Brief Summary

Pregnenolone is a "neurosteroid" and possesses intrinsic behavioral and brain effects in animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is hypothesized that the combined effect of antipsychotic agents and pregnenolone would be beneficial in the treatment of negative,depressive, and cognitive symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 21, 2008

Status Verified

May 1, 2008

First QC Date

September 9, 2005

Last Update Submit

May 20, 2008

Conditions

Schizophrenia

Keywords

SchizophreniaPregnenoloneNeurosteroids

Outcome Measures

Primary Outcomes (8)

  • The computerized Cambridge Neuropsychological Test Automated Battery (CANTAB).

  • The Positive and Negative Syndrome Scale.

  • The Scale for the Assessment of Negative Symptoms.

  • The Calgary Depression Scale for Schizophrenia.

  • The Hamilton Scale for Anxiety.

  • Extrapyramidal Symptom Rating Scale.

  • Barnes Akathisia Scale.

  • Abnormal Involuntary Movement Scale.

Secondary Outcomes (1)

  • The Scale to assess Unawareness of Mental Disorder (SUMD, Amador, 1999).

Interventions

PregnenoloneDRUG

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Ability and willingness to sign informed consent for participation in the study

You may not qualify if:

  • Evidence of organic brain damage, mental retardation, alcohol or drug abuse
  • Prostate nodules or cancer.
  • Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding.
  • History of ischemic cardiac disease.
  • Renal disease.
  • Hepatic dysfunction.
  • Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer.
  • Women with a history of uterine cancer.
  • Patients with a known hypersensitivity to androgens.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sha'ar Menashe Mental Health

Hadera, 38814, Israel

Location

Related Publications (3)

  • Ritsner M, Gibel A, Ram E, Maayan R, Weizman A. Alterations in DHEA metabolism in schizophrenia: two-month case-control study. Eur Neuropsychopharmacol. 2006 Feb;16(2):137-46. doi: 10.1016/j.euroneuro.2005.07.007. Epub 2005 Sep 1.

    PMID: 16139994BACKGROUND

  • Ritsner M, Gibel A, Maayan R, Ratner Y, Ram E, Biadsy H, Modai I, Weizman A. Cortisol/dehydroepiandrosterone ratio and responses to antipsychotic treatment in schizophrenia. Neuropsychopharmacology. 2005 Oct;30(10):1913-22. doi: 10.1038/sj.npp.1300747.

    PMID: 15870835BACKGROUND

  • Ritsner MS, Gibel A, Shleifer T, Boguslavsky I, Zayed A, Maayan R, Weizman A, Lerner V. Pregnenolone and dehydroepiandrosterone as an adjunctive treatment in schizophrenia and schizoaffective disorder: an 8-week, double-blind, randomized, controlled, 2-center, parallel-group trial. J Clin Psychiatry. 2010 Oct;71(10):1351-62. doi: 10.4088/JCP.09m05031yel. Epub 2010 Jun 15.

    PMID: 20584515DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Michael S. Ritsner, MD, PhD

    Sha'ar Menashe Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

January 1, 2005

Study Completion

May 1, 2007

Last Updated

May 21, 2008

Record last verified: 2008-05

Locations

IL(1)