Back to resultsPregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia (PREG-2008)
Primary Purpose
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorders
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Pregnenolone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Neurosteroids, Pregnenolone, Augmentation
Eligibility Criteria
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.
Sites / Locations
- Shaar Menashe MHC and Tirat Carmel MHC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1 Pregnenolone
2 Placebo
Arm Description
50 mg/day
1 caps.
Outcomes
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)
Secondary Outcome Measures
Global Assessment of Functioning
The Cambridge Neuropsychological Test Automated Battery (CANTAB)
Extrapyramidal Symptom Rating Scale
Full Information
NCT ID
NCT00847600
First Posted
February 18, 2009
Last Updated
December 14, 2010
Sponsor
Sha'ar Menashe Mental Health Center
Collaborators
Tirat Carmel Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00847600
Brief Title
Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia
Acronym
PREG-2008
Official Title
Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia: an 8-week, Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sha'ar Menashe Mental Health Center
Collaborators
Tirat Carmel Mental Health Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorders
Keywords
Schizophrenia, Neurosteroids, Pregnenolone, Augmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 Pregnenolone
Arm Type
Experimental
Arm Description
50 mg/day
Arm Title
2 Placebo
Arm Type
Placebo Comparator
Arm Description
1 caps.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pregnenolone
Intervention Description
50 mg, caps.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
caps
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Global Assessment of Functioning
Time Frame
baseline, 2, 4, 6, and 8 weeks
Title
The Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time Frame
baseline, 4 and 8 weeks
Title
Extrapyramidal Symptom Rating Scale
Time Frame
baseline, 2, 4, 6, and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Ritsher, MD, PhD
Organizational Affiliation
Technion and Shaar Menashe MHC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anatoly Kreinin, MD, PhD
Organizational Affiliation
Technion and Tirat Carmel Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Shaar Menashe MHC and Tirat Carmel MHC
City
Hadera
ZIP/Postal Code
38814
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
17123790
Citation
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.
Results Reference
background
Learn more about this trial
Pregnenolone Augmentation in the Treatment of Patients With Recent-Onset Schizophrenia
We'll reach out to this number within 24 hrs