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ISRCTN
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ISRCTN54975957
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ClinicalTrials.gov identifier
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Public title
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Mirtazapine augmentation enhances cognitive and negative symptoms in schizophrenic patients treated with risperidone: a randomised controlled trial
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Scientific title
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The effect of mirtazapine augmentation of risperidone in the treatment of cognitive and negative symptoms of schizophrenia: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Bundang CHA Institutional Review Board (Ethics Committee) approved on the 22nd December 2008 (ref: 2008-15)
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Study design
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Double-blind randomised controlled trial
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Countries of recruitment
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South Korea
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Disease/condition/study domain
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Schizophrenia
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2008
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Anticipated end date
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31/03/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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25
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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Bundang CHA Hospital (South Korea)
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Trial website
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Publications
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Contact name
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Prof
Sang Hyuk
Lee
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Address
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Department of Psychiatry
Bundang CHA Hospital
CHA University School of Medicine
351 Yatap-Dong
Bundang-Gu
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City/town
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Seongnam-Si
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Zip/Postcode
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463-712
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Country
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Korea, South
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Sponsor
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Bundang CHA Hospital (South Korea)
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Address
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c/o Sang-Hyuk Lee, M.D.,Ph.D.
Assistant Professor, Department of Psychiatry
CHA University School of Medicine
351 Yatap-Dong
Bundang-Gu
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City/town
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Seongnam-Si
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Zip/Postcode
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463-712
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Country
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Korea, South
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Date applied
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27/05/2009
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Last edited
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01/12/2009
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Date ISRCTN assigned
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01/12/2009
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