Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?
NCT ID: NCT01481883
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
13 participants
INTERVENTIONAL
2012-01-31
2019-02-28
Brief Summary
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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
Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Raloxifene Hydrochloride 120mg oral per day
120mg raloxifene plus antipsychotic drug
Raloxifene Hydrochloride
120mg daily - 1 capsule daily for 12 week trial
Placebo tablet - one per day
Lactose pill plus antipsychotic medication
Placebo
1 capsule daily for 12 week trial
Interventions
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Raloxifene Hydrochloride
120mg daily - 1 capsule daily for 12 week trial
Placebo
1 capsule daily for 12 week trial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* DSM-IV diagnosis of schizophrenia, schizoaffective or schizophreniform
* 18- 45 years
* Able to give informed consent
* PANSS total score \> 60 (1 - 7 scale) and a score of 4 (moderate) or more on two or more of the following PANSS items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness
Exclusion Criteria
* Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilization.
* Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance abuse or dependence during the last six months, or consumption of more than 30gm of alcohol (three standard drinks) per day
* Smoking more than 20 cigarettes per day.
* Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet.
18 Years
45 Years
MALE
No
Sponsors
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The Alfred
OTHER
Responsible Party
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Jayashri Kulkarni, Professor
Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?
Principal Investigators
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Jayashri Kulkarni, Phd,FRANZCP
Role: PRINCIPAL_INVESTIGATOR
Monash Alfred Psychiatry Research Centre
Locations
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Alfred Hospital
Melbourne, Victoria, Australia
Countries
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References
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Kulkarni J, de Castella A, Headey B, Marston N, Sinclair K, Lee S, Gurvich C, Fitzgerald PB, Burger H. Estrogens and men with schizophrenia: is there a case for adjunctive therapy? Schizophr Res. 2011 Feb;125(2-3):278-83. doi: 10.1016/j.schres.2010.10.009. Epub 2010 Nov 9.
Related Links
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Centre website
Other Identifiers
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486/11
Identifier Type: -
Identifier Source: org_study_id