Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?
The aim of this project is to investigate the effect of Raloxifene 120mg in men with schizophrenia. This trial will adopt a 12 week randomised controlled model.
Hypotheses 1: That the men receiving adjunctive selective estrogen receptor modulators (SERM) will have a significantly greater reduction in psychosis symptoms over the course of the study than men receiving adjunctive placebo.
Hypotheses 2: That the men receiving adjunctive SERM will have a significantly greater improvement in cognitive function than men receiving adjunctive placebo
Drug: Raloxifene Hydrochloride
|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:||A Randomised Controlled Trial of Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?|
- Change from Baseline to 12 week follow up in PANSS-positive and negative syndrome scale [ Time Frame: baseline, week2, week4, week 6, week 8, week 10, week 12 ] [ Designated as safety issue: No ]Positive and Negative Symptom Schedule (PANSS): The PANSS will be performed at baseline and at weeks 2,4,6,8,10 and 12. The PANSS consists of a Positive Scale (7 positive symptom constructs), a Negative Scale (7 negative symptom constructs) and a General Psychopathology Scale (16 symptom constructs). For each patient, the scale will be administered by the same trained rater. The PANSS provides a well standardised method of evaluating and monitoring psychotic symptoms. The rater is trained and recertified against an internationally recognised "gold standard".
- Montgomery Asberg Depression Rating Scale (MADRS): [ Time Frame: baseline, week2, week4, week 6, week 8, week 10, week 12 ] [ Designated as safety issue: No ]Montgomery Asberg Depression Rating Scale (MADRS): The MADRS will be performed at baseline, then at weeks 2,4,6,8,10 and 12. Many patients with schizophrenia have co-existing depression, hence monitoring of depression is important.
- MATRICS Consensus Cognitive Battery [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]MATRICS Consensus Cognitive Battery (MCCB): The MATRICS test battery will be conducted at baseline and at study completion to quantify changes in cognitive functioning. This standardized battery assess the key separable cognitive deficits in schizophrenia and has a high test-retest reliability. The MATRICS comprises 7 Domains of which we will be assessing speed of processing, working memory, verbal learning, visual learning and reasoning and problem solving.
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]A neuropsychological test battery will be conducted at baseline and study completion to quantify changes in cognitive functioning. The RBANS comprises 12 subtests that are used to calculate five index scores (Immediate Memory; Visuospatial/Constructional; Language; Attention and Delayed Memory) and a total score. There are alternate forms to be used at each time point to avoid practice effects. The inclusion of the RBANS will allow direct comparisons in cognitive functioning with our other estrogen trials.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Experimental: Raloxifene Hydrochloride 120mg oral per day
120mg raloxifene plus antipsychotic drug
Drug: Raloxifene Hydrochloride
120mg daily - 1 capsule daily for 12 week trial
Placebo Comparator: Placebo tablet - one per day
Lactose pill plus antipsychotic medication
1 capsule daily for 12 week trial
With the recent advent of selective estrogen receptor modulators (SERMS), such as raloxifene hydrochloride, there is the potential to harness the positive estrogenic effect on central nervous system (CNS) neurotransmitter systems. While the CNS effects of raloxifene have not been fully studied, its actions are mediated through binding to estrogen receptors and can thereby regulate gene expression that is ligand, tissue or gene specific. By inference then, raloxifene would be expected to impact on dopamine and serotonin pathways in a similar fashion to unconjugated estrogen.
This study aims to examine the impact of adjunctive SERM (120mg oral Raloxifene daily) treatment on the psychopathology and cognition of men with schizophrenia and related disorders
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481883
|Contact: Emmy Gavrilidis, BaAppSci||+61 3 9076 6913 ext firstname.lastname@example.org|
|Melbourne, Victoria, Australia, 3004|
|Contact: Jaysahri Kulkarni, Phd, FRANZCP +61 3 9076 6924 ext 66924 email@example.com|
|Contact: Anthony De Castella, M App Sci +61 3 90766564 ext 66564 firstname.lastname@example.org|
|Principal Investigator:||Jayashri Kulkarni, Phd,FRANZCP||Monash Alfred Psychiatry Research Centre|