The Use of Selective Estrogen Receptor Modulators in the Treatment of Schizophrenia- a Pilot Study

The aim of the project is to investigate the use of raloxifene (a new form of estrogen) as a treatment for schizophrenia in postmenopausal women.

Official Title

The Use of Selective Estrogen Receptor Modulators in the Treatment of Schizophrenia- a Pilot Study

Conditions

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• PANSS score at trial completion (12 weeks)

Secondary Outcome Measures:

• MADRS score at trial completion (12 weeks)
• Cognitive Test scores at trial completion (12 weeks)
• Adverse Symptom Checklist score at trial completion (12 weeks)
• Hormone level change over study period (12 weeks)

Raloxifene is a selective estrogen receptor modulator (SERM) which means that it can affect the central nervous system effects of estrogen (eg: improving emotional symptoms, memory, information processing and concentration), without adversely affecting reproductive tissue / organs such as breast, uterus and ovaries. This is a double blind, placebo controlled, 3 month duration study comparing the psychotic symptom response between three groups of postmenopausal women with schizophrenia. One group will receive standard antipsychotic medication plus 60mg Raloxifene, the second group receives standard antipsychotic medication plus Hormone Therapy(estradiol 2mg oral per day + dyhydroprogesterone 10mg oral per day) and the third group receives standard antipsychotic medication plus oral placebo. Hypothesis 1: That the women receiving adjunctive raloxifene or HT would have a quicker recovery from psychotic symptoms, as measured on the rating scales, compared with the women receiving adjunctive placebo. Hypothesis 2: That the Raloxifene group would have better cognitive improvement than the other two groups.

Study Start

October 2002; Study completion: April 2007

Eligibility & Criteria

• Ages Eligible for Study: 45 Years – 70 Years
• Genders Eligible for Study: Female

Inclusion Criteria:

• Female aged over 45 years
• Current diagnosis of DSM-IV Schizophrenia, Schizoaffective or Schizophreniform Disorder
• Symptom rating greater than 60 on the PANSS at baseline/screening
• Patient able to give informed consent
• Patient post menopausal (confirmed by hormone assay and Greene Climacteric Scale plus Menstrual Cycle Questionnaire)

Exclusion Criteria:

• Clinically significant concomitant medical or neurological condition or history of venous thromboembolic event
• High suicide/aggression Risk in the opinion of the investigator.
• If patient’s psychotic illness is directly related to illicit substance abuse or has a history of substance abuse or dependence in the past 6 months
• Smoking more than 20 cigarettes per day
• Use of any form of hormones or hormone therapy
• Illness causing immobilisation
• Undiagnosed postmenopausal vaginal bleeding
• Consumption of more than 30gm of alcohol (3 standard drinks)per day.

Total Enrolment

60

Contact Details

Alfred Psychiatry Research Centre, Alfred Hospital, Melbourne, Victoria, 3181, Australia