Evaluation of Mirtazapine and Folic Acid for Schizophrenia: (RECOVERY2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Capital Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT01263080
First received: December 17, 2010
Last updated: June 30, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01263080

Contacts
Contact: Ling Zhang, M.D. 86-10-58303186 lingzhang_bj@yahoo.com.cn

Locations
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.         
Sponsors and Collaborators
Capital Medical University
Investigators
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
Mirtazapine
Mianserin
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on September 14, 2014