Selective Estrogen Receptor Modulators for Women of Child-bearing Age With Schizophrenia

NCT02354001 | Completed Phase 4

• 1 other identifier: 94/06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the project is to investigate the use of Raloxifene (a new form of estrogen) in the treatment of young women with schizophrenia and schizoaffective disorder. Raloxifene is a Selective Estrogen Receptor Modulator (SERM),which means that it can affect the central nervous system (CNS) effects of estrogen (eg. improving emotional symptoms, memory, information processing and concentration), without adversely affecting reproductive tissue/organs such as breast, uterus and ovaries. The investigators are conducting a double-blind, placebo controlled, three month study comparing the psychotic symptom response of women with schizophrenia in both groups. One group will receive standard antipsychotic medication plus 120mg Raloxifene, while the second group will receive standard antipsychotic medication plus oral placebo.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; mental illness; serm; raloxifene; clinical trial

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Positive and Negative Syndrome Scale (PANSS)

  baseline and 12 weeks

Secondary Outcomes (2)

• Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score

  baseline and 12 weeks

• Change from baseline in Cognitive Test scores- MATRICS Consensus Cognitive Battery (MCCB) and Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)

  baseline and 12 weeks

Study Arms (2)

Raloxifene Hydrochloride

EXPERIMENTAL

120 mg per capsule (1 tablet daily)

Drug: Raloxifene hydrochloride

placebo tablet

PLACEBO COMPARATOR

1 tablet daily for 12 weeks

Drug: Placebo

Interventions

Raloxifene hydrochloride DRUG

120mg daily- 1 capsule for 12 week trial

Also known as: Evista

Raloxifene Hydrochloride

Placebo DRUG

1 capsule daily for 12 week trial - lactose

Also known as: Lactose

placebo tablet

Eligibility Criteria

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

You may qualify if:

• Physically well
• A current DSM-IV diagnosis of schizophrenia or related disorder.
• years
• Premenopausal (regular menstrual cycles and follicle stimulating hormone \< 40 mIU/ml; for hysterectomised women, FSH\< 40mIU/ml and estradiol\> 120pmol/L)
• 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.
• No abnormality observed during physical breast examination.
• Documented normal PAP smear and pelvic examination in the preceding two years.

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, or undiagnosed vaginal bleeding.
• Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation.
• 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
• Monash University: collaborator

Study Sites (1)

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Thomas N, Gurvich C, Hudaib AR, Gavrilidis E, Kulkarni J. Dissecting the syndrome of schizophrenia: Associations between symptomatology and hormone levels in women with schizophrenia. Psychiatry Res. 2019 Oct;280:112510. doi: 10.1016/j.psychres.2019.112510. Epub 2019 Aug 8.

  PMID: 31415936 DERIVED

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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 3, 2015
• Study Start: April 1, 2011
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

AU (1)