Evaluation of Mirtazapine and Folic Acid for Schizophrenia:A Large Simple 2x2 Factorial Trial.
- Conditions
- Schizophorenia with suboptimal responce to standard antipsychotics.
- Registration Number
- EUCTR2009-014469-19-FI
- Lead Sponsor
- Oxford University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 53
diagnosis of DSM-IV schizophrenia
? active psychotic symptoms – i.e. hallucinations, delusions, thought disorder
? not meeting criteria for current manic episode including schizoaffective disorder
? inpatient or outpatient
? aged 16 to 70 years.
? able and willing to consent to participate
? currently taking effective dose of antipsychotic (see Appendix 1 for dose ranges)
? no antidepressant treatment within last two weeks and not considering treatment for depression
? not taking clozapine
? clinically appropriate to change or augment treatment*
? adjunctive mirtazapine appears reasonable and both investigator and patient are uncertain whether it will offer any benefit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- contraindication to investigational medicinal products
- pregnancy, breast-feeding or planning a pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method