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

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

Primary Outcome Measures

Name	Time	Method
1. Positive and Negative Syndrome Scale (PANSS), collected for each patient at week 0, week 2, week 4, and week 8<br>2. Scale for the Assessment of Negative Symptoms (SANS), collected for each patient at week 0, week 2, week 4, and week 8<br>3. Digit Span of K-WAIS (Korean-Wechsler Adult Intelligence Scale), collected at weeks 0 and 8<br>4. Controlled Oral Word Association Test (COWAT), collected at weeks 0 and 8<br>5. Korean-Complex Figure Test (K-CFT), collected at weeks 0 and 8 <br>6. Korean-Auditory Verbal Learning Test (K-AVLT), collected at weeks 0 and 8 <br>7. Estimated intelligence quotient (IQ) by the sum of Vocabulary scores and Block Design scores on the K-WAIS, collected at weeks 0 and 8 <br>8. Timed Coding Test, collected at weeks 0 and 8

Secondary Outcome Measures

Name	Time	Method
1. Barnes Akathisia Rating Scale, collected at weeks 0 and 8<br>2. Simpson-Angus Scale for Expyramidal Side-effects, collected at weeks 0 and 8<br>3. Clinical Global Impression (CGI), collected at weeks 0 and 8<br>4. Hamilton Rating Scale for Depression (HAMD), collected at weeks 0 and 8 <br>5. Body weight, collected at weeks 0 and 8<br>6. Abdominal circumference, collected at weeks 0 and 8