Back to resultsEvaluation of Mirtazapine and Folic Acid for Schizophrenia: (RECOVERY2)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
mirtazapine
folic acid placebo
mirtazapine placebo
folic acid
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring mirtazapine, folic acid, schizophrenia
Eligibility Criteria
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- Have previously completed or withdrawn from this study, or participated in a clinical trial of another drug within 30 days.
Sites / Locations
- Beijing Anding Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
mirtazapine+folic acid
mirtazapine+folic acid placebo
mirtazapine placebo+folic acid
mirtazapine placebo+folic acid placebo
Arm Description
mirtazapine 30mg QD, folic acid 0.4mg QD
mirtazapine 30mg QD, folic acid placebo 1 tablet QD
mirtazapine placebo 1 tablet QD, folic acid 0.4mg QD
mirtazapine placebo 1 tablet QD, folic acid placebo 1 tablet QD
Outcomes
Primary Outcome Measures
To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia
Secondary Outcome Measures
To compare the efficacy of folic acid and placebo for treatment of symptoms of schizophrenia
To compare the efficacy of mirtazapine and placebo for treatment of negative symptoms of schizophrenia
To compare the efficacy of folic acid and placebo for treatment of negative symptoms of schizophrenia
To compare the safety and tolerability of mirtazapine and placebo in patients with schizophrenia
To compare the safety and tolerability of folic acid and placebo in patients with schizophrenia
Full Information
NCT ID
NCT01263080
First Posted
December 17, 2010
Last Updated
August 1, 2016
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01263080
Brief Title
Evaluation of Mirtazapine and Folic Acid for Schizophrenia:
Acronym
RECOVERY2
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
mirtazapine, folic acid, schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mirtazapine+folic acid
Arm Type
Active Comparator
Arm Description
mirtazapine 30mg QD, folic acid 0.4mg QD
Arm Title
mirtazapine+folic acid placebo
Arm Type
Active Comparator
Arm Description
mirtazapine 30mg QD, folic acid placebo 1 tablet QD
Arm Title
mirtazapine placebo+folic acid
Arm Type
Active Comparator
Arm Description
mirtazapine placebo 1 tablet QD, folic acid 0.4mg QD
Arm Title
mirtazapine placebo+folic acid placebo
Arm Type
Placebo Comparator
Arm Description
mirtazapine placebo 1 tablet QD, folic acid placebo 1 tablet QD
Intervention Type
Drug
Intervention Name(s)
mirtazapine
Other Intervention Name(s)
Remeron
Intervention Description
mirtazapine 30mg QD
Intervention Type
Drug
Intervention Name(s)
folic acid placebo
Other Intervention Name(s)
Folic placebo
Intervention Description
folic acid placebo 1 tablet QD
Intervention Type
Drug
Intervention Name(s)
mirtazapine placebo
Other Intervention Name(s)
Remeron placebo
Intervention Description
mirtazapine placebo 1 tablet QD
Intervention Type
Drug
Intervention Name(s)
folic acid
Other Intervention Name(s)
vitamin B 9
Intervention Description
folic acid 0.4mg QD
Primary Outcome Measure Information:
Title
To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia
Time Frame
baseline, week4, week8, week12
Secondary Outcome Measure Information:
Title
To compare the efficacy of folic acid and placebo for treatment of symptoms of schizophrenia
Time Frame
baseline, week4, week8, week12
Title
To compare the efficacy of mirtazapine and placebo for treatment of negative symptoms of schizophrenia
Time Frame
baseline, week4, week8, week12
Title
To compare the efficacy of folic acid and placebo for treatment of negative symptoms of schizophrenia
Time Frame
baseline, week4, week8, week12
Title
To compare the safety and tolerability of mirtazapine and placebo in patients with schizophrenia
Time Frame
baseline, week4, week8, week12
Title
To compare the safety and tolerability of folic acid and placebo in patients with schizophrenia
Time Frame
baseline, week4, week8, week12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Wang, M.D.
Organizational Affiliation
Beijing Anding Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anding Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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