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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12605000577617
• Date of registration: 04/10/2005
• Prospective Registration: No
• Primary sponsor: University of Melbourne
• Public title: Mirtazapine add-on therapy in the treatment of schizophrenia with atypical neuroleptics: A double-blind, randomised, placebo controlled trial
• Scientific title: Mirtazapine add-on therapy in the treatment of schizophrenia with atypical neuroleptics: A double-blind, randomised, placebo controlled trial
• Date of first enrolment: 01/06/2004
• Target sample size: 40
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12605000577617.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Dr Seetal Dodd

• Name: Dr Seetal Dodd

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Schizophrenia;
Schizophrenia

Mental Health - Schizophrenia

Intervention(s)

6-week trial of mirtazapine (30 mg/day) in addition to antipsychotic treatment as usual.

Primary Outcome(s)

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(s)

Clinical global impression (CGI)[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.]

Hamilton Depression rating scale (HAMD)[Measured at baseline, and at weeks 1, 2, 4 and 6.]

Source(s) of Monetary Support

Organon

Secondary Sponsor(s)

Royal Adelaide Hospital

Ethics review

Status: Not approved
Approval date:
Contact:

Barwon Health

Status: Not approved
Approval date:
Contact:

Glenside Hospital

Status: Not approved
Approval date:
Contact:

Northern Health