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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00847600
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : December 15, 2010
Tirat Carmel Mental Health Center
Information provided by:
Sha’ar Menashe Mental Health Center

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; 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 Type : Interventional  (Clinical Trial)
Estimated 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 : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Global Assessment of Functioning [ Time Frame: baseline, 2, 4, 6, and 8 weeks ]
  2. The Cambridge Neuropsychological Test Automated Battery (CANTAB) [ Time Frame: baseline, 4 and 8 weeks ]
  3. Extrapyramidal Symptom Rating Scale [ Time Frame: baseline, 2, 4, 6, and 8 weeks ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00847600

Shaar Menashe MHC and Tirat Carmel MHC
Hadera, Israel, 38814
Sponsors and Collaborators
Sha’ar Menashe Mental Health Center
Tirat Carmel Mental Health Center
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

Responsible Party: Technion and Shaar Menashe MHC Identifier: NCT00847600     History of Changes
Other Study ID Numbers: MEN-8-11-08
08TGF-1189 Stanley grant
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: December 2010

Keywords provided by Sha’ar Menashe Mental Health Center:

Additional relevant MeSH terms:
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders