None listed
Conditions
Brief summary
The objectives of this study are to determine the extent to which 1) a hormone intervention therapy will reduce psychotic symptoms and improve cognitive function in patients with schizophrenia, 2) genetic changes in the oestrogen receptor alpha gene can be used to predict cognitive improvement in patients with schizophrenia, and 3) hormone intervention therapy will modify brain activation as assessed by functional Magnetic Resonance Imaging in patients with schizophrenia. Our hypotheses are: 1) adjunctive administration of a selective estrogen receptor modulator (SERM) will improve clinical symptoms and estrogen-sensitive cognitive deficits exhibited by patients with schizophrenia, 2) common variation in the oestrogen receptor alpha gene will predict the degree of cognitive improvement with SERM treatment in patients with schizophrenia, 3) adjunctive SERM treatment will modify dysfunctional brain activity during a cognitive test in patients with schizophrenia, and 4) that the altered SERM related dorsolateral prefrontal activity will be related to specific oestrogen receptor alpha genotypes.
Interventions
raloxifene at a daily oral intake dose of 120 mg/day. A thirteen week double-blind, cross-over design will be used in which patients will receive either raloxifene or placebo as an adjunctive treatment to their previously stabilized antipsychotic medication. Following treatment in the first 6-week phase, patients will then enter a one week wash-out before entering the second 6-week phase consisting of the alternate treatment (raloxifene or placebo). Thus, in total, participants will be treated w
raloxifene at a daily oral intake dose of 120 mg/day. A thirteen week double-blind, cross-over design will be used in which patients will receive either raloxifene or placebo as an adjunctive treatment to their previously stabilized antipsychotic medication. Following treatment in the first 6-week phase, patients will then enter a one week wash-out before entering the second 6-week phase consisting of the alternate treatment (raloxifene or placebo). Thus, in total, participants will be treated with raloxifene for a period of 6 weeks.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Male and female patients with schizophrenia between the ages of 18 and 45 who have been receiving any antipsychotic medication for at least one year can participate.
Exclusion criteria
Any patients with a psychiatric diagnosis other than schizophrenia or a history of substance dependence (within past 5 years), head injuries with loss of consciousness, seizures, central nervous system infection, diabetes, hypertension, lactose intolerance, superficial thrombophlebitis (pain and inflammation in a vein just under the skin), thromboembolic disease (blood clotting disease), congestive heart failure, or who have had reactions to raloxifene will be excluded.
Outcome results
None listed