PREG-2008: Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia

Sponsor

Sha'ar Menashe Mental Health Center (Other)

Overall Status

Completed

CT.gov ID

NCT00847600

Collaborator

Tirat Carmel Mental Health Center (Other)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizophreniform Disorder Schizoaffective Disorders	Dietary Supplement: Pregnenolone Dietary Supplement: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia: an 8-week, Randomized, Double-blind, Placebo-controlled Trial

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pregnenolone 50 mg/day	Dietary Supplement: Pregnenolone 50 mg, caps.
Placebo Comparator: 2 Placebo 1 caps.	Dietary Supplement: Placebo caps

Arm

Intervention/Treatment

Experimental: 1 Pregnenolone

50 mg/day

Dietary Supplement: Pregnenolone

50 mg, caps.

Placebo Comparator: 2 Placebo

1 caps.

Dietary Supplement: Placebo

caps

Outcome Measures

Primary Outcome Measures

The Clinical Global Impression Scale (CGI-S) The Positive and Negative Syndrome Scale (PANSS) The Scale for the Assessment of Negative Symptoms (SANS) [baseline, 2, 4, 6, and 8 weeks]

Secondary Outcome Measures

Global Assessment of Functioning [baseline, 2, 4, 6, and 8 weeks]
The Cambridge Neuropsychological Test Automated Battery (CANTAB) [baseline, 4 and 8 weeks]
Extrapyramidal Symptom Rating Scale [baseline, 2, 4, 6, and 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-40 years of age, any ethnic group, either sex.
DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorders (36).
Duration of illness less than 5 years since onset first psychotic episode.
Subjects entering the study must score at least 4 on the Clinical Global Impression Scale.
At least two weeks of ongoing treatment with current antipsychotic agents during the pre-treatment stabilization period.
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.
No change in anticholinergic, benzodiazepine, or mood stabilizer medications for the pre-treatment stabilization period.
No anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 8-week duration of the study.
Ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion Criteria:

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.
Unstable medical illness or neurologic illness (seizures, CVA); history of prostate, breast, uterine, or ovarian cancer.
Pregnant women, use of oral contraceptives or other hormonal supplementation such as estrogen.
Current active suicidal and/or homicidal ideation, intent, or plan.
Known allergy to study medication.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaar Menashe MHC and Tirat Carmel MHC	Hadera		Israel	38814

Sponsors and Collaborators

Sha'ar Menashe Mental Health Center
Tirat Carmel Mental Health Center

Investigators

Study Chair: Michael S Ritsher, MD, PhD, Technion and Shaar Menashe MHC
Study Director: Anatoly Kreinin, MD, PhD, Technion and Tirat Carmel Mental Health Center