Condition category
Mental and Behavioural Disorders
Date applied
27/05/2009
Date assigned
01/12/2009
Last edited
01/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sang Hyuk Lee

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Bundang CHA Hospital (South Korea)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes