Meta AnalysisID 3877
孕烯醇酮辅助治疗精神分裂症及其他精神病性障碍
CRD42017081355
Pregnenolone is a naturally-occuring neurosteroid, which has several, diverse neurochemical actions and which has recently been posited to play a role in the neurobiology of chronic psychotic disorders. There has been a
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Record Fields
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- Meta Analysis Id
- 3877
- Evidence Id
- 12435
- Core Evidence Id
- 12435
- Source Meta Analysis Id
- 3834
- Herb2 Meta Analysis Id
- HBMA003834
- Crd Id
- CRD42017081355
- Title
- Adjunctive pregnenolone therapy for the treatment of schizophrenia and other psychotic disorders
- Review Question
- Pregnenolone is a naturally-occuring neurosteroid, which has several, diverse neurochemical actions and which has recently been posited to play a role in the neurobiology of chronic psychotic disorders. There has been a suggestion that treatment with Pregnenolone may represent a novel mechanism for the treatment of psychotic illness, particularly the treatment of negative and cognitive psychotic symptoms, which historically have proved challenging to treat.
- Study Type Included
- Randomised, placebo-controlled trials only.
- Condition Being Studied
- Schizophrenia, schizoaffective disorer or other psychotic disorder.
- Participant
- This study has pragmatic inclusion criteria, including all adult samples (over 18 years old) with a formal DSM or ICD diagnosis of schizophrenia, schizoaffective disorder or other psychotic disorder. Exclusions would include samples with dual-diagnosis (e.g. allied diagnosis of alcohol or substance dependence).
- Animal
- Human Disease Modelled
- Intervention
- Adjunctive treatment with oral Pregnenolone, at any prescribed dose for any duration of study.
- Comparator Control
- Placebo-controlled treatment group.
- Main Outcome
- The mean difference in psychotic symptomatology (total Positive and Negative Syndrome Scale, PANSS [Kay et al 1987], score) between Pregnenolone and placebo therapy. Measures of effect The mean difference will be measured between the start of the trial and the end of the trial, irrespective of trial length.
- Outcome Measure
- Additional Outcome
- Psychotic symptomatology subscale changes: - Positive symptoms (PANSS positive symptoms subscale); - Negative symptoms (PANSS negative symptoms subscale and Scale for the Assessment of Negative Symptoms, SANS [Andreasen 1989]); and - General psychopathology (PANSS general psychopathology subscale). Measures of response to therapy, using the Clinical Global Impression - CGI-S and CGI-I - scales. Change in participants' global rating of functioning using a validated scale, such as the Global Assessment of Functioning (GAF), (UPSA) and WHO Disability Assessment Scale (WHODAS). Results of depression and anxiety severity rating scale results, reported using a validated, quantitative tool for the assessment of depression and anxiety severity (e.g. Calgary Depression Scale for Schizophrenia, Hamilton Depression Rating Scale, Montgomery-Asberg Depression Rating Scale, Hospital Anxiety and Depression Rating Scale, Beck Anxiety Inventory, etc). Measures of global cognitive function or specific cognitive domains, using validated neuropsychological tools or assessment (Schizophrenia Cognition Ratin Scale, MATRICS Consensus Cognitive Battery, etc). Reported changes in extrapyramidal symptom severity, recorded using validated scales (Extrapyramidal Symptom Rating Scale, Simpson-Angus Scale, Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale, etc). Reported adverse-effects and study non-completion rates, as a proxy for treatment acceptability. Measures of effect Again, the mean differences will be measured between the start of the trial and the end of the trial, irrespective of trial length.
- Study Method
- Intervention, Meta-analysis, Qualitative synthesis
- Keyword
- Combined Modality Therapy; Humans; Pregnenolone; Psychotic Disorders; Schizophrenia
- Contact
- Dr Christopher Hopkins [email protected]
- Organisational Affiliation
- Berkshire Healthcare NHS Foundation Trust www.berkshire.nhs.uk
- Funding Source
- Other Selection Criteria
- Final Publication
- Results of this study were presented orally and in poster format at the Royal College of Psychiatrists' International Congress 2018.
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- England
- Review Stage
- Review Completed not published
- First Submission Date
- 2018-02-19
- Registration Date
- 2017-11-17
- Anticipated Start Date
- 2017-11-10
- Anticipated Completion Date
- 2018-02-28
- Title Cn
- 孕烯醇酮辅助治疗精神分裂症及其他精神病性障碍
- Title En
- Adjunctive pregnenolone therapy for the treatment of schizophrenia and other psychotic disorders
- Bilingual Status
- complete