Efficacy of Pregnenolone in Patients With Schizophrenia

NCT00615511 | Completed Phase 2

• 2 other identifiers: PRE050400784105T-658
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; schizoaffective disorder; negative symptoms; cognition

Outcome Measures

Primary Outcomes (1)

• SANS - Scale for the Assessment of Negative Symptoms

  every month for 4 months

Secondary Outcomes (1)

• Quality of Life

  every two months for four months

Study Arms (2)

placebo

PLACEBO COMPARATOR

Approximately one third of subjects

Dietary Supplement: placebo pregnenolone

Pregnenolone

EXPERIMENTAL

Dietary Supplement: pregnenolone

Interventions

placebo pregnenolone DIETARY_SUPPLEMENT

Sugar pill, taken twice a day

placebo

pregnenolone DIETARY_SUPPLEMENT

500mg in tablet form taken orally twice a day

Pregnenolone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Stanley Medical Research Institute: collaborator

Study Sites (3)

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

Piscataway, New Jersey, 08854, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Weill Medical College of Cornell University

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Pregnenolone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic 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

• Jason J Kim, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 21, 2015

Record last verified: 2015-12

Locations

US (3)