Schizophrenia Clinical Trial
Official title:
Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial
To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Physically well. - A current DSM-V diagnosis of schizophrenia or related disorder. - 18- 65 years - Able to give informed consent. - PANSS total score between 40 and 90 and a score of 4 (moderate) or more on two or more of the following PANSS items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness. - Documented normal PAP smear and pelvic examination in the preceding two years. - Stable psychotropic medication for previous 4 weeks - Normal breast ultrasound - IQ > 70 (as determined by the WAIS IV subtests) - English language proficiency (in order to provide informed consent and complete cognitive test battery) Exclusion Criteria: - 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 a history of severe traumatic brain injury or significant neurological or 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 dependence during the last six months (with the exclusion of caffeine and/or nicotine dependence). - Women aged 40 or over who have not had a normal mammogram in the last 24 months - Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill. - Pregnant (HCG will be measured at screening) - Breastfeeding - Planned changes to psychotropic medication or psychotherapy regimen. |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Alfred Psychiatry Research Centre | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
The Alfred | Monash Health, Monash University |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Schizophrenia symptoms | Symptoms of schizophrenia as measured on the Positive and Negative Symptom Scale (PANSS).
Subscales: Positive, Negative, General Psychopathology. Positive scale: 7 Items, (minimum score = 7, maximum score = 49). Negative scale: 7 Items, (minimum score = 7, maximum score = 49). General Psychopathology scale:16 Items, (minimum score = 16, maximum score = 112). PANSS Total score (summed from subscales): minimum = 30, maximum = 210 For all items, higher values indicate increased symptom severity. |
12 Weeks | |
Secondary | Cognition | The neuropsychological battery will include subtests from the following batteries:
MATRICS Consensus Cognitive Battery (MCCB) comprises 7 domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. The Repeatable Battery for Neuropsychological Status (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. A verbal fluency task (Controlled Oral Word Association Task; COWAT), visual attention task (Trails A and B) and measures of premorbid intellect (Test of Premorbid Functioning; TOPF) will also be included. Eye tracking will be an optional extra and will be recorded using The EyeLink (SR Research Ltd). Participants will fixate and/or shift their gaze in response to a number of stimuli, appearing on the screen, as requested by the assessor. |
12 Weeks |
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