A Phase 4 interventional study of Raloxifene Hydrochloride and Placebo in Schizophrenia, Schizoaffective Disorder and Schizophreniform Disorder, sponsored by The Alfred. Completed at 1 site in Australia. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by The Alfred · Phase 4, Interventional, and Treatment
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
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
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 13 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →The Alfred is the lead sponsor of 47 studies on the registry; 4 are open to participants now.
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120mg raloxifene plus antipsychotic drug
Drug: Raloxifene Hydrochloride
Lactose pill plus antipsychotic medication
Drug: Placebo
120mg daily - 1 capsule daily for 12 week trial
Also known as: Evista, Raloxifene
1 capsule daily for 12 week trial
Also known as: Lactose
Change from Baseline to 12 week follow up in PANSS-positive and negative syndrome scale
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".
Time frame: baseline, week2, week4, week 6, week 8, week 10, week 12
Montgomery Asberg Depression Rating Scale (MADRS):
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.
Time frame: baseline, week2, week4, week 6, week 8, week 10, week 12
MATRICS Consensus Cognitive Battery
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.
Time frame: Baseline, week 12
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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.
Time frame: Baseline, week 12
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Raloxifene
The Alfred