A Phase 2/3 interventional study of Pregnenolone and Placebo in Schizophrenia, sponsored by National Research Foundation, Singapore. Completed at 1 site in Singapore. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-10-06.
Sponsored by National Research Foundation, Singapore · Phase 2/3, Interventional, and Treatment
The purpose of this study is to determine whether pregnenolone will demonstrate significant improvements in cognitive functioning and negative symptoms compared to patients receiving placebo.
Aims:
Schizophrenia is one of the most disabling disorders to afflict mankind. Despite the low lifetime prevalence of schizophrenia (1% world-wide), it has an enormous burden in both economic cost and human suffering. There is currently no cure for schizophrenia and its cause is not well understood. Patients with schizophrenia also suffer from negative symptoms (loss of drive, apathy, poverty of speech) and severe cognitive impairments especially with memory, attention, processing of information - the latter of which is most robustly correlated with their role functioning in the community. Addressing these impairments with effective interventions is thus critically important but at this present moment, there is no effective treatment. Recent emerging data from animal studies and a pilot study on small group of patients with schizophrenia suggest that neurosteroids such as pregnenolone may be relevant to schizophrenia pathophysiology and treatment of neurocognitive impairments. This study will be a 10-week randomised double-blind placebo-controlled trial of the efficacy and safety of pregnenolone. Our hypothesis is patients with schizophrenia randomized to pregnenolone will demonstrate significant improvements in cognitive functioning and negative symptoms compared to patients receiving placebo. The primary aims of the study are to demonstrate the efficacy of pregnenolone in comparison to placebo in patients with schizophrenia which are assessed by changes (from baseline) in the composite score of the MATRICS Consensus Cognitive Battery (MCCB), BACS and the Scale for Assessment of Negative Symptoms (SANS). Changes in functionality will be assessed by the University of California Performance Based Skills Assessment (UPSA). Safety will be assessed with laboratory tests, well established scales for side effects as well as with a side-effects checklist.
Objectives:
To demonstrate the efficacy of pregnenolone in comparison to placebo in patients with schizophrenia and with cognitive impairment from randomization (Week 2) to Week 10 by using MATRICS Consensus Cognitive Battery, BACS, Scale for Assessment of Negative Symptoms, Performance Based Skills Assessment - Brief Version and Clinical Global Impression -Improvement (CGI-I).Additional safety data on pregnenolone in patients with schizophrenia will be provided.
Methodology:
The proposed study is a single-site, randomized, double blind placebo-controlled comparison of adjunctive pregnenolone and placebo. A total sample will consist of 120 clinically stable inpatients and outpatients with DSM IV schizophrenia, with 60 subjects randomized to each group. A best estimate diagnostic approach will be utilized, in which information from the Structured Clinical Interview for DSM-IV will be supplemented by information from family informants, previous psychiatrists, and medical records to generate a diagnosis. There will be a 2 week, single-blind placebo lead-in evaluation phase, in which subjects will undergo baseline diagnostic and medical testing, including a physical examination, Electrocardiogram (ECG), Complete Blood Counts (CBC), complete metabolic panel, urine toxicology, and urinalysis. The study is designed to confirm the pilot study results (n=9 per group; total of 18 patients of 21 randomized who completed at least 4 weeks of treatment) in a larger clinical trial (n=60 per group, 120 patients total). Identical to our pilot study, patients will be seen for a total of 6 study visits (every two weeks). The placebo arm is essential as there are no standard therapies for cognitive defects as yet.
Potential Benefits:
While patients may not personally be helped by taking part in this study, their participation may lead to knowledge that will help better understand the illness. It may also lead to better treatment for cognitive deficits and negative symptoms in schizophrenia.
Potential Risks:
Obtaining blood can cause pain, bleeding, bruising, or swelling at the site of the needle prick. There is a risk that some questions on the questionnaires might upset the patients or cause psychological distress. There are no known severe risks that had been associated with taking pregnenolone.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 120 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →This is the only study on the registry with National Research Foundation, Singapore as lead sponsor.
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Exclusion Criteria:
Subjects with a history of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders (e.g., unstable angina, seizures, cerebrovascular accident, decompensate congestive heart failure, CNS infection, HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
Drug: Pregnenolone
Drug: Placebo
Pregnenolone 50 mg BID x 14 days, followed by Pregnenolone 300 mg per day for 14 days (200 mg qAM and 100 mg qPM), followed by Pregnenolone 500 mg per day for the remainder of the 8-week trial (300 mg qAM and 200 mg qPM)
Placebo 50 mg BID x 14 days, followed by Placebo 300 mg per day for 14 days (200 mg qAM and 100 mg qPM), followed by Placebo 500 mg per day for the remainder of the 8-week trial (300 mg qAM and 200 mg qPM)
Improvement in composite score of the MATRICS Consensus Cognitive Battery (MCCB) and BACS.
Time frame: 10 weeks
Improvement of negative symptoms as assessed by the Scale for Assessment of Negative Symptoms (SANS).
Time frame: 10 weeks
To provide additional safety data on pregnenolone in patients with schizophrenia via reported serious and non serious adverse events.
Time frame: 10 weeks
Improvement of functional outcome by the University of California Performance Based Skills Assessment (UPSA-B)at Week 2, 6 and 10.
Time frame: 10 weeks
Efficacy outcome variables will be evaluated by the Clinical Global Impression -Improvement (CGI-I) score at week 2 to week 10.
Time frame: 10 weeks
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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