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

This study has been completed.
Sponsor:
Collaborator:
Tirat Carmel Mental Health Center
Information provided by:
Sha’ar Menashe Mental Health Center
ClinicalTrials.gov Identifier:
NCT00847600
First received: February 18, 2009
Last updated: December 14, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorders
 Dietary Supplement: Pregnenolone
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sha’ar Menashe Mental Health Center:

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) [ Time Frame: baseline, 2, 4, 6, and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Assessment of Functioning [ Time Frame: baseline, 2, 4, 6, and 8 weeks ] [ Designated as safety issue: No ]
  • The Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: baseline, 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Extrapyramidal Symptom Rating Scale [ Time Frame: baseline, 2, 4, 6, and 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Pregnenolone
50 mg/day
 Dietary Supplement: Pregnenolone
50 mg, caps.
Placebo Comparator: 2 Placebo
1 caps.
 Dietary Supplement: Placebo
caps

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847600

Locations
Israel
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
  More Information

Publications:

Responsible Party: Technion and Shaar Menashe MHC
ClinicalTrials.gov Identifier: NCT00847600     History of Changes
Other Study ID Numbers: MEN-8-11-08, 08TGF-1189 Stanley grant
Study First Received: February 18, 2009
Last Updated: December 14, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sha’ar Menashe Mental Health Center:
Schizophrenia
Neurosteroids
Pregnenolone
Augmentation

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 26, 2012