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

ISRCTN	ISRCTN54975957
DOI	https://doi.org/10.1186/ISRCTN54975957
Secondary identifying numbers	N/A

Submission date: 27/05/2009
Registration date: 01/12/2009
Last edited: 01/12/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sang Hyuk Lee
Scientific

Department of Psychiatry
Bundang CHA Hospital
CHA University School of Medicine
351 Yatap-Dong
Bundang-Gu
Seongnam-Si
463-712
Korea, South

Study information

Study design	Double-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of mirtazapine augmentation of risperidone in the treatment of cognitive and negative symptoms of schizophrenia: a randomised controlled trial
Study objectives	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(s)	Bundang CHA Institutional Review Board (Ethics Committee) approved on the 22nd December 2008 (ref: 2008-15)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Mirtazapine, risperidone
Primary outcome measure	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 study start date	01/10/2008
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	25
Key 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)
Key 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
Date of first enrolment	01/10/2008
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Korea, South

Study participating centre

Department of Psychiatry

Seongnam-Si
463-712
Korea, South

Sponsor information

Bundang CHA Hospital (South Korea)
Hospital/treatment centre

c/o Sang-Hyuk Lee, M.D.,Ph.D.
Assistant Professor, Department of Psychiatry
CHA University School of Medicine
351 Yatap-Dong
Bundang-Gu
Seongnam-Si
463-712
Korea, South

"ROR"	https://ror.org/04yka3j04

Funders

Funder type

Hospital/treatment centre

Bundang CHA Hospital (South Korea)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan