MedDataX Logo

Efficacy of Pregnenolone in Patients With Schizophrenia

NCT ID: NCT00615511

Last Updated: 2015-12-21

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pregnenolone is a steroid health supplement which is readily available in health food stores. We are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. We do not require you to stop your existing treatment in order to enter the study. After four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizoaffective Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

schizophrenia schizoaffective disorder negative symptoms cognition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

Approximately one third of subjects

Group Type PLACEBO_COMPARATOR

placebo pregnenolone

Intervention Type DIETARY_SUPPLEMENT

Sugar pill, taken twice a day

Pregnenolone

Group Type EXPERIMENTAL

pregnenolone

Intervention Type DIETARY_SUPPLEMENT

500mg in tablet form taken orally twice a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placebo pregnenolone

Sugar pill, taken twice a day

Intervention Type DIETARY_SUPPLEMENT

pregnenolone

500mg in tablet form taken orally twice a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-65
* Diagnosis of schizophrenia or schizoaffective disorder
* No new medication for past 3 months and stable dose for past 4 weeks
* SANS (Negative symptom) score of 20 or above

Exclusion Criteria

* Significant dementia or head trauma.
* Seizure during past year.
* Substance dependence in past 6 months or positive urine drug screen.
* History of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers.
* Steroid metabolism disorder, e.g.Cushings or Addison's disease.
* Taking steroids other than birth control or post-menopausal hormones.
* Women who are pregnant or nursing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanley Medical Research Institute

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jason Kim

Assistant Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jason J Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare

Piscataway, New Jersey, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Weill Medical College of Cornell University

White Plains, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05T-658

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRE0504007841

Identifier Type: -

Identifier Source: org_study_id