Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for people with schizophrenia.

• Conditions: MedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Schizophrenia; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2009-014469-19-IT
• Lead Sponsor: IVERSITY OF OXFORD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-02
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

1. diagnosis of DSM-IV schizophrenia; 2. active psychotic symptoms (i.e. hallucinations, delusions, thought disorder); 3. minimum PANSS score 60; 4. inpatient or outpatient; 5. aged 16 to 70 years; 6. able and willing to consent to participate; 7. currently taking effective dose of antipsychotic; 8. clinically appropriate to change or augment treatment; 9. adjunctive mirtazapine appears reasonable and both investigator and patient are uncertain whether it will offer any benefit; 10. not pregnant, breast-feeding or planning a pregnancy; 11. adhering to antipsychotic treatment; 12. drug treatment stable.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Meeting criteria for current manic episode, including schizoaffective disorder; 2. Current (i.e. within last 2 weeks) antidepressant treatment or considering treatment for depresison; 3. Contraindications to investigational medicinal products. If contraindication is to folic acid only, the patient can be randomised to the mirtazapine/placebo comparison only; 4. Currently taking clozapine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified