NCT01263080

Evaluation of Mirtazapine and Folic Acid for Schizophrenia:

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	mirtazapine	mirtazapine 30mg QD
DRUG	folic acid placebo	folic acid placebo 1 tablet QD
DRUG	mirtazapine placebo	mirtazapine placebo 1 tablet QD
DRUG	folic acid	folic acid 0.4mg QD

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-12-20
• Last updated: 2016-08-02

Locations

1 site across 1 country: China