Raloxifene Augmentation in Patients with a Schizophrenia spectrum Disorder
- Conditions
- schizophrenia, schizophreniform disorder, schizoaffective disorder and psychotic disorder NOS
- Registration Number
- NL-OMON27943
- Lead Sponsor
- MC Utrecht
- Brief Summary
Heringa, Sophie M., Marieke JH Begemann, Angelique J. Goverde, and Iris EC Sommer. "Sex hormones and oxytocin augmentation strategies in schizophrenia: A quantitative review." Schizophrenia research (2015).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 148
Inclusion Criteria
A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS)
- Capable of understanding the purpose and details of the study in order to provide written informed consent;
Exclusion Criteria
- Pre-existing cardiovascular disease;
- History of thrombo-embolic events;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes are change in symptom severity, measured with PANSS and BNSS and changes in cognition, measured with BACS.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are changes in personal and social performance (measured with PSP), change in severity of thought disorder (measured with TALD), quality of life (measured with EQ-5D), use of healthcare and non-healthcare resources, comorbid depression (measured with BDI), cognitive control (measured with a Stroop Test), language production (measured by analyzing speech samples), hormonal and inflammatory biomarkers, and psychophysiological parameters of basic information processing (i.e. P300 and N100, measured using electroencephalography).