Evaluation of Mirtazapine and Folic Acid for Schizophrenia:

NCT01263080 | Completed Phase 4 DMC

• 1 other identifier: RECOVERY2
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Keywords

mirtazapine; folic acid; schizophrenia

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia

  baseline, week4, week8, week12

Secondary Outcomes (5)

• To compare the efficacy of folic acid and placebo for treatment of symptoms of schizophrenia

  baseline, week4, week8, week12

• To compare the efficacy of mirtazapine and placebo for treatment of negative symptoms of schizophrenia

  baseline, week4, week8, week12

• To compare the efficacy of folic acid and placebo for treatment of negative symptoms of schizophrenia

  baseline, week4, week8, week12

• To compare the safety and tolerability of mirtazapine and placebo in patients with schizophrenia

  baseline, week4, week8, week12

• To compare the safety and tolerability of folic acid and placebo in patients with schizophrenia

  baseline, week4, week8, week12

Study Arms (4)

mirtazapine+folic acid

ACTIVE COMPARATOR

mirtazapine 30mg QD, folic acid 0.4mg QD

Drug: mirtazapine; Drug: folic acid

mirtazapine+folic acid placebo

ACTIVE COMPARATOR

mirtazapine 30mg QD, folic acid placebo 1 tablet QD

Drug: mirtazapine; Drug: folic acid placebo

mirtazapine placebo+folic acid

ACTIVE COMPARATOR

mirtazapine placebo 1 tablet QD, folic acid 0.4mg QD

Drug: mirtazapine placebo; Drug: folic acid

mirtazapine placebo+folic acid placebo

PLACEBO COMPARATOR

mirtazapine placebo 1 tablet QD, folic acid placebo 1 tablet QD

Drug: folic acid placebo; Drug: mirtazapine placebo

Interventions

mirtazapine DRUG

mirtazapine 30mg QD

Also known as: Remeron

mirtazapine+folic acid; mirtazapine+folic acid placebo

folic acid placebo DRUG

folic acid placebo 1 tablet QD

Also known as: Folic placebo

mirtazapine placebo+folic acid placebo; mirtazapine+folic acid placebo

mirtazapine placebo DRUG

mirtazapine placebo 1 tablet QD

Also known as: Remeron placebo

mirtazapine placebo+folic acid; mirtazapine placebo+folic acid placebo

folic acid DRUG

folic acid 0.4mg QD

Also known as: vitamin B 9

mirtazapine placebo+folic acid; mirtazapine+folic acid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Anding Hospital, Capital Medical University

Beijing, Beijing Municipality, 100088, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Mirtazapine; Folic Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring

Study Officials

• Gang Wang, M.D.

  Beijing Anding Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-director of Affective Disorder Center, Beijing Anding Hospital

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 20, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 2, 2016

Record last verified: 2016-08

Locations

CN (1)