Schizophrenia | Evaluation of Mirtazapine and Folic Acid for Schizophrenia:
Schizophrenia research study
What is the primary objective of this study?
Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for patients with schizophrenia
Who is eligible to participate?
Inclusion Criteria: 1. Inpatients or outpatients age 18 to 70 years; 2. Meet DSM-IV criteria for schizophrenia; 3. Signed an informed consent form by patients or their legally acceptable representatives; 4. PANSS total score >=60 and at least one item of P1, P2, P3, P5 or P6 >=4 to ensure subject has current active psychotic symptoms - i.e. hallucinations, delusions, thought disorder; 5. Subjects who are currently taking effective dose of antipsychotic; 6. Women must agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Exclusion Criteria: 1. Meet any other DSM-IV Axis I disorders; 2. Meet DSM-IV criteria for substance abuse or dependence; 3. Have been treatment-resistant to 2 or more kinds of antipsychotics with sufficient dosage for at least 4 weeks, or require clozapine treatment, or have received clozapine treatment within 1 month prior to randomization; 4. Subjects are actively suicidal or judged clinically to be at risk of serious suicidal or violent behavior in the opinion of the investigator; 5. Have serious or unstable medical illness (e.g., cardiovascular disease, neurologic, hematologic, renal, hepatic, immunologic, endocrine, or other systemic illness), or have any clinically significant abnormality on laboratory test or ECG which indicate severe medical conditions; 6. Have received electroconvulsive therapy within 28 days before randomization; 7. Have received long acting antipsychotic within 1 treatment cycle before randomization; 8. Have received antidepressant within 14 days, or have received MAOIs within 4 weeks before randomization or require antidepressive treatment; 9. History of prostatic hypertrophy or dysuria; 10. History of narrow-angle glaucoma or elevation of intraocular pressure; 11. Known or suspected history of allergy or have contradiction to mirtazapine or folic acid; 12. Known have currently requirement of taking mirtazapine or folic acid; 13. Women who are pregnant or nursing; 14. Have previously completed or withdrawn from this study, or participated in a clinical trial of another drug within 30 days.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:mirtazapinemirtazapine 30mg QD
Drug:folic acid placebofolic acid placebo 1 tablet QD
Drug:mirtazapine placebomirtazapine placebo 1 tablet QD
Drug:folic acidfolic acid 0.4mg QD
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
mirtazapine+folic acidmirtazapine 30mg QD, folic acid 0.4mg QD
mirtazapine+folic acid placebomirtazapine 30mg QD, folic acid placebo 1 tablet QD
mirtazapine placebo+folic acidmirtazapine placebo 1 tablet QD, folic acid 0.4mg QD
mirtazapine placebo+folic acid placebomirtazapine placebo 1 tablet QD, folic acid placebo 1 tablet QD
Start Date: November 2010
Completed Date: December 2012
Phase: Phase 4
Primary Outcome: To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia
Secondary Outcome: To compare the efficacy of folic acid and placebo for treatment of symptoms of schizophrenia
Study sponsors, principal investigator, and references
Principal Investigator: Gang Wang, M.D.
Lead Sponsor: Capital Medical University