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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
333
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, China
To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia
Time frame: baseline, week4, week8, week12
To compare the efficacy of folic acid and placebo for treatment of symptoms of schizophrenia
Time frame: baseline, week4, week8, week12
To compare the efficacy of mirtazapine and placebo for treatment of negative symptoms of schizophrenia
Time frame: baseline, week4, week8, week12
To compare the efficacy of folic acid and placebo for treatment of negative symptoms of schizophrenia
Time frame: baseline, week4, week8, week12
To compare the safety and tolerability of mirtazapine and placebo in patients with schizophrenia
Time frame: baseline, week4, week8, week12
To compare the safety and tolerability of folic acid and placebo in patients with schizophrenia
Time frame: baseline, week4, week8, week12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
folic acid 0.4mg QD