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

Schizophrenia Clinical Trial

— PREG-2008  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847600
• Other study ID #: MEN-8-11-08
• Secondary ID: 08TGF-1189 Stanl
• Status: Completed
• Phase: Phase 4
• First received: February 18, 2009
• Last updated: December 14, 2010
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Sha’ar Menashe Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorders
• Schizophrenia
• Schizophreniform Disorder

Intervention

Dietary Supplement:
• Pregnenolone
50 mg, caps.
• Placebo
caps

Locations

Country	Name	City	State
Israel	Shaar Menashe MHC and Tirat Carmel MHC	Hadera

Sponsors (2)

Lead Sponsor	Collaborator
Sha’ar Menashe Mental Health Center	Tirat Carmel Mental Health Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. Epub 2006 Nov 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Global Assessment of Functioning		baseline, 2, 4, 6, and 8 weeks	No
Secondary	The Cambridge Neuropsychological Test Automated Battery (CANTAB)		baseline, 4 and 8 weeks	No
Secondary	Extrapyramidal Symptom Rating Scale		baseline, 2, 4, 6, and 8 weeks	Yes