Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of mirtazapine augmentation of risperidone in the treatment of cognitive and negative symptoms of schizophrenia: a randomised controlled trial
Acronym
Study hypothesis
Our hypothesis is that mirtazapine augmentation to the 'typical' atypical antipsychotics, risperidone that demonstrates potent inhibitors of of 5-hydroxytryptamine2 (5-HT2), alpha-2 adrenergic receptors can enhance cognitive function and reduce negative symptoms in patients with schizophrenia.
Ethics approval
Bundang CHA Institutional Review Board (Ethics Committee) approved on the 22nd December 2008 (ref: 2008-15)
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Schizophrenia
Intervention
Mirtazapine was added to the on-going pharmacotherapy with risperidone in the mirtazapine group. The initial dosage was 15 mg/day at bedtime for the first two weeks. Thereafter, a daily dose of 30 mg/day was given at bedtime through the remainder of the study (six weeks). Doses of risperidone were fixed for the duration of the study.
Intervention type
Drug
Phase
Phase IV
Drug names
Mirtazapine, risperidone
Primary outcome measures
1. Positive and Negative Syndrome Scale (PANSS), collected for each patient at week 0, week 2, week 4, and week 8
2. Scale for the Assessment of Negative Symptoms (SANS), collected for each patient at week 0, week 2, week 4, and week 8
3. Digit Span of K-WAIS (Korean-Wechsler Adult Intelligence Scale), collected at weeks 0 and 8
4. Controlled Oral Word Association Test (COWAT), collected at weeks 0 and 8
5. Korean-Complex Figure Test (K-CFT), collected at weeks 0 and 8
6. Korean-Auditory Verbal Learning Test (K-AVLT), collected at weeks 0 and 8
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
8. Timed Coding Test, collected at weeks 0 and 8
Secondary outcome measures
1. Barnes Akathisia Rating Scale, collected at weeks 0 and 8
2. Simpson-Angus Scale for Expyramidal Side-effects, collected at weeks 0 and 8
3. Clinical Global Impression (CGI), collected at weeks 0 and 8
4. Hamilton Rating Scale for Depression (HAMD), collected at weeks 0 and 8
5. Body weight, collected at weeks 0 and 8
6. Abdominal circumference, collected at weeks 0 and 8
Overall trial start date
01/10/2008
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25
Participant 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
Recruitment start date
01/10/2008
Recruitment end date
31/03/2009
Locations
Countries of recruitment
Korea, South
Trial participating centre
Department of Psychiatry
Seongnam-Si
463-712
Korea, South
Funders
Funder type
Hospital/treatment centre
Funder name
Bundang CHA Hospital (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary