Evaluation of Mirtazapine and Folic Acid for Schizophrenia: (RECOVERY2)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Negative Symptoms |
Drug: mirtazapine and folic acid Drug: mirtazapine, folic acid placebo Drug: mirtazapine placebo, folic acid Drug: mirtazapine placebo, folic acid placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
- To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia [ Time Frame: baseline, week4, week8, week12 ] [ Designated as safety issue: No ]
- To compare the efficacy of folic acid and placebo for treatment of symptoms of schizophrenia [ Time Frame: baseline, week4, week8, week12 ] [ Designated as safety issue: No ]
- To compare the efficacy of mirtazapine and placebo for treatment of negative symptoms of schizophrenia [ Time Frame: baseline, week4, week8, week12 ] [ Designated as safety issue: No ]
- To compare the efficacy of folic acid and placebo for treatment of negative symptoms of schizophrenia [ Time Frame: baseline, week4, week8, week12 ] [ Designated as safety issue: No ]
- To compare the safety and tolerability of mirtazapine and placebo in patients with schizophrenia [ Time Frame: baseline, week4, week8, week12 ] [ Designated as safety issue: Yes ]
- To compare the safety and tolerability of folic acid and placebo in patients with schizophrenia [ Time Frame: baseline, week4, week8, week12 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 330 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: mirtazapine, folic acid,add-on therapy |
Drug: mirtazapine and folic acid
mirtazapine 30mg QD,folic acid 0.4mg QD
|
| Active Comparator: mirtazapine, folic acid placebo, add-on therapy |
Drug: mirtazapine, folic acid placebo
mirtazapine 30mg QD,folic acid placebo 1 tablet QD
|
| Active Comparator: mirtazapine placebo, folic acid, add-on therapy |
Drug: mirtazapine placebo, folic acid
mirtazapine placebo 1 tablet QD,folic acid 0.4mg QD
|
| Placebo Comparator: mirtazapine placebo, folic acid placebo, add-on therapy |
Drug: mirtazapine placebo, folic acid placebo
mirtazapine placebo 1 tablet QD,folic acid placebo 1 tablet QD
|
Detailed Description:
The combination of mirtazapine plus antipsychotic potentially offers considerable benefit for patients with schizophrenia. Folic acid is a promising adjunctive therapy for schizophrenia that may also provide benefits for patients with other mental disorders. Furthermore the effects of folic acid may be affected by genotype.
The trial will investigate the effects of adding mirtazapine and the effects of adding folic acid to treatments for schizophrenia. At randomisation, patients will be separately randomised to mirtazapine or placebo and to folic acid or placebo.
Randomised, double-blind, placebo-controlled 2x2 factorial trial with 12-week follow-up.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Inpatients or outpatients age 18 to 70 years;
- Meet DSM-IV criteria for schizophrenia;
- Signed an informed consent form by patients or their legally acceptable representatives;
- 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;
- Subjects who are currently taking effective dose of antipsychotic;
- Women must agree to practice an effective method of birth control if they are sexually active before entry and throughout the study.
Exclusion Criteria:
- Meet any other DSM-IV Axis I disorders;
- Meet DSM-IV criteria for substance abuse or dependence;
- 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;
- Subjects are actively suicidal or judged clinically to be at risk of serious suicidal or violent behavior in the opinion of the investigator;
- 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;
- Have received electroconvulsive therapy within 28 days before randomization;
- Have received long acting antipsychotic within 1 treatment cycle before randomization;
- Have received antidepressant within 14 days, or have received MAOIs within 4 weeks before randomization or require antidepressive treatment;
- History of prostatic hypertrophy or dysuria;
- History of narrow-angle glaucoma or elevation of intraocular pressure;
- Known or suspected history of allergy or have contradiction to mirtazapine or folic acid;
- Known have currently requirement of taking mirtazapine or folic acid;
- Women who are pregnant or nursing;
- Have previously completed or withdrawn from this study, or participated in a clinical trial of another drug within 30 days.
Contacts and Locations| Contact: Ling Zhang, M.D. | 86-10-58303186 | lingzhang_bj@yahoo.com.cn |
| China, Beijing | |
| Beijing Anding Hospital, Capital Medical University | Recruiting |
| Beijing, Beijing, China, 100088 | |
| Contact: Ye Zhao, Master 86-10-58303236 zzzy209@126.com | |
| Principal Investigator: Gang Wang, M.D. | |
| Sub-Investigator: Ling Zhang, M.D. | |
| Sub-Investigator: Yanfang Zhang, M.D. | |
| Sub-Investigator: Yanmin Zhang, M.D. | |
| Sub-Investigator: Xuemei Wang, M.D. | |
| Sub-Investigator: Li Ren, M.D. | |
| Sub-Investigator: Haiting Yu, M.D. | |
| Sub-Investigator: Yan Wang, M.D. | |
| Principal Investigator: | Gang Wang, M.D. | Beijing Anding Hospital, Capital Medical University |
More Information
No publications provided
| Responsible Party: | Beijing Anding Hospital, Capital Medical University |
| ClinicalTrials.gov Identifier: | NCT01263080 History of Changes |
| Other Study ID Numbers: | RECOVERY2 |
| Study First Received: | December 17, 2010 |
| Last Updated: | June 30, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Capital Medical University:
|
mirtazapine folic acid schizophrenia |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Folic Acid Vitamin B Complex Hematinics Mirtazapine Mianserin Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematologic Agents Therapeutic Uses |
Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Serotonin Antagonists Serotonin Agents Antidepressive Agents, Second-Generation |
ClinicalTrials.gov processed this record on May 16, 2013