Mirtazapine augmentation enhances cognitive and negative symptoms in schizophrenic patients treated with risperidone: a randomised controlled trial

Completed

• Conditions: Schizophrenia; Mental and Behavioural Disorders

• Registration Number: ISRCTN54975957
• Lead Sponsor: Bundang CHA Hospital (South Korea)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-01
• Last Update Posted: 2015-01-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Aged between 21 and 70 years, either sex
2. Diagnosed with schizophrenia based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (SCID)
3. Receiving treatment of oral risperidone (Risperdal Quicklet®) or RLAI (risperidone long acting-injection) as outpatients. In addition, the subjects had to have been stable for at least eight weeks in an outpatient setting immediately prior to initiation of this study.
4. Presence of positive or negative symptoms or both, resulting in the illness of at least moderate severity (greater than or equal to 4 on the Clinical Global Impression [CGI] Severity Scale)

Exclusion Criteria

1. Evidence of organic mental disorder or mental retardation
2. Severe drug or alcohol dependence that required inpatient treatment and/or detoxification
3. Presence of a depressive episode. To exclude subjects with depressive episodes, the Hamilton Rating Scale for Depression (HAMD) was used (patients who scored more than 17 on HAMD were excluded).
4. Other conditions, such as a serious medical condition, a history of bipolar or schizoaffective disorder, substance misuse, suicidality, possibility of pregnancy, lactation, or inability/unwillingness to use contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified