Mirtazapine add-on therapy in the treatment of schizophrenia with atypical neuroleptics: A double-blind, randomised, placebo controlled trial

Phase 4

Completed

• Conditions: Schizophrenia; Mental Health - Schizophrenia

• Registration Number: ACTRN12605000577617
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Diagnosis of schizophrenia confirmed by the Mini International Neuropsychiatric Interview (MINI).Currently being treated with an atypical antipsychotic.

Exclusion Criteria

Patients with significant medical illnesses and patients on any other psychotropic agents except benzodiazepines, patients who have a history of any other major psychiatric disorder, and patients meeting criteria for substance abuse or who regularly consume over 3 alcoholic drinks daily, pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant difference by week 6 between mirtazapine treated and placebo treated groups using the Positive and negative symptoms scale (PANSS).[Measurements at baseline and weeks 1, 2, 4 and 6.]

Secondary Outcome Measures

Name	Time	Method
Clinical global impression (CGI)[Measured at baseline, and at weeks 1, 2, 4 and 6.];Hamilton Depression rating scale (HAMD)[Measured at baseline, and at weeks 1, 2, 4 and 6.];Simpson Angus Scale[Measured at baseline, and at weeks 1, 2, 4 and 6.]