Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia

NCT ID: NCT00847600

Last Updated: 2010-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-12-31

Brief Summary

Pregnenolone (PREG) is a neurosteroid, which displays multiple effects on the central nervous system, and may be beneficial in the treatment of patients with schizophrenia. Our recent 8-week, randomized, double-blind trial among patients with chronic schizophrenia and schizoaffective disorders, in which PREG versus placebo and DHEA have been added to conventional or atypical antipsychotics have yielded encouraging results with low-dose PREG (30 mg/day; ClinicalTrials.gov identifier NCT00140192; Ritsner et al., in press). The goal of the present study is to evaluate the potential role of PREG's augmentation compared to placebo in the treatment of young patients with newly diagnosed schizophrenia or schizophreniform or schizoaffective disorders.

In a 8-week, randomized, double-blind placebo-controlled trial PREG (50 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 60 patients with recent-onset schizophrenia or schizophreniform or schizoaffective disorders. Participants will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. A battery of research instruments will be used for assessment of psychopathology, cognitive functions, side effects, general functioning and quality of life. In addition blood PREG levels will be monitored at baseline and during the study. The study is powered to detect moderate between-group effects on persistent positive, negative and cognitive symptoms.

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorders

Keywords

Schizophrenia; Neurosteroids; Pregnenolone; Augmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1 Pregnenolone

50 mg/day

Group Type: EXPERIMENTAL

Pregnenolone

Intervention Type: DIETARY_SUPPLEMENT

50 mg, caps.

2 Placebo

1 caps.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

caps

Interventions

Pregnenolone

50 mg, caps.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

caps

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. 18-40 years of age, any ethnic group, either sex.

2. DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorders (36).

3. Duration of illness less than 5 years since onset first psychotic episode.

4. Subjects entering the study must score at least 4 on the Clinical Global Impression Scale.

5. At least two weeks of ongoing treatment with current antipsychotic agents during the pre-treatment stabilization period.

6. Stable symptoms throughout the 2-week pre-treatment stabilization period. Clinical stability is defined as two consecutive weekly CGI ratings with no change in score, and with no more than a 20% change in PANSS total score.

7. No change in anticholinergic, benzodiazepine, or mood stabilizer medications for the pre-treatment stabilization period.

8. No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 8-week duration of the study.

9. Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion Criteria

1. Evidence of serious neurologic or endocrine disorder, for example severe head trauma, seizure disorder, dementia, Cushings disease, or thyroid disorder, mental retardation, alcohol or drug abuse, substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician.

2. Unstable medical illness or neurologic illness (seizures, CVA); history of prostate, breast, uterine, or ovarian cancer.

3. Pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen.

4. Current active suicidal and/or homicidal ideation, intent, or plan.

5. Known allergy to study medication.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tirat Carmel Mental Health Center

OTHER_GOV

Sponsor Role: collaborator

Sha'ar Menashe Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Technion and Shaar Menashe MHC

Principal Investigators

Michael S Ritsher, MD, PhD

Role: STUDY_CHAIR

Technion and Shaar Menashe MHC

Anatoly Kreinin, MD, PhD

Role: STUDY_DIRECTOR

Technion and Tirat Carmel Mental Health Center

Locations

Shaar Menashe MHC and Tirat Carmel MHC

Hadera, , Israel

Countries

Israel

References

Ritsner M, Maayan R, Gibel A, Weizman A. Differences in blood pregnenolone and dehydroepiandrosterone levels between schizophrenia patients and healthy subjects. Eur Neuropsychopharmacol. 2007 Apr;17(5):358-65. doi: 10.1016/j.euroneuro.2006.10.001. Epub 2006 Nov 21.

Reference Type: BACKGROUND

PMID: 17123790 (View on PubMed)

Other Identifiers

08TGF-1189 Stanley grant

Identifier Type: -

Identifier Source: secondary_id

MEN-8-11-08

Identifier Type: -

Identifier Source: org_study_id