Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?

NCT01481883 | Completed Phase 4 DMC

• 1 other identifier: 486/11
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

Schizophrenia; Mental Illness; SERM; Raloxifene

Outcome Measures

Primary Outcomes (1)

• 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".

  baseline, week2, week4, week 6, week 8, week 10, week 12

Secondary Outcomes (3)

• Montgomery Asberg Depression Rating Scale (MADRS):

  baseline, week2, week4, week 6, week 8, week 10, week 12

• MATRICS Consensus Cognitive Battery

  Baseline, week 12

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  Baseline, week 12

Study Arms (2)

Raloxifene Hydrochloride 120mg oral per day

EXPERIMENTAL

120mg raloxifene plus antipsychotic drug

Drug: Raloxifene Hydrochloride

Placebo tablet - one per day

PLACEBO COMPARATOR

Lactose pill plus antipsychotic medication

Drug: Placebo

Interventions

Raloxifene Hydrochloride DRUG

120mg daily - 1 capsule daily for 12 week trial

Also known as: Evista, Raloxifene

Raloxifene Hydrochloride 120mg oral per day

Placebo DRUG

1 capsule daily for 12 week trial

Also known as: Lactose

Placebo tablet - one per day

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physically well
• DSM-IV diagnosis of schizophrenia, schizoaffective or schizophreniform
• 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

You may not qualify if:

• Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.
• 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.

Sponsors & Collaborators

• The Alfred: lead

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• 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.

  PMID: 21062669 BACKGROUND

Related Links

• Centre website

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mental Disorders

Interventions

Raloxifene Hydrochloride; Lactose

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Jayashri Kulkarni, Phd,FRANZCP

  Monash Alfred Psychiatry Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 30, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

AU (1)