Comparison of the effect of lithium plus quetiapine with lithium plus risperidone in children and adolescents with bipolar Idisorder (manic or mixed episode) in a double blind randomized clinical trial
The aim of this trial is to compare the effect of lithium plus quetiapine with lithium plus risperidone in children and adolescents with bipolar Idisorder (manic or mixed episode). In this randomized double blind trial, thirthy patients who will be hospitalized at razi psychiatric hospital will be nrecruited. Patients will be randomly allocated to lithium + quetiapine or lithium+ risperidone for a 6-week.Quetiapine dose is uo to 600mg/day and risperidone up to 6mg/ day. Patients will be assessed at baseline and after 2, 4 and 6 weeks. The primary efficacy measure is change in Yoing Mania Rating Scale score across the study period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205059645N1
Registration date:2012-10-29, 1391/08/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-29, 1391/08/08
Registrant information
Name
Nastaran Habibi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21334012209
Email address
na.habibi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lithium plus quetiapine with lithium plus risperidone in children and adolescents with bipolar Idisorder (manic or mixed episode) in a double blind randomized clinical trial
Public title
The effect of quetiapine in children and adolescents with bipolar I disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ages 10-17 with bipolar I disorder, manic or mixed episode
Exclusion criteria: YMRS score < 20 ( young mania rating scale); mood symptoms secondary to substance intoxication or withdrawal; substance use disorders 3 months prior to study; mental retardation; severe medical diseases; serious neurologic disorders; autistic disorder; history of hypersensitivity or intolerance or nonresponse to quetiapine or risperidone or lithium; use of long acting antipsychotics 3 months prior to study; use of antidepressants or antipsychotics 1 week prior to study; use of psychostimulants or benzodiazepines 72 hours prior to study
Age
From 10 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
7189/ت/801/91
Health conditions studied
1
Description of health condition studied
Bipolar disorder type I, manic or mixed episode
ICD-10 code
F31-1, F31
ICD-10 code description
Bipolar affective disorder, current episode manic without psychotic symptoms, Bipolar affective disorder, current episode manic with psychotic symptoms, Bipolar affective disorder, current episode mixed
Primary outcomes
1
Description
severity of manic or mixed episode
Timepoint
every two weeks
Method of measurement
Young Mania Rating Scale and Children's Depression Rating Scale
Secondary outcomes
1
Description
psychotic symptoms
Timepoint
every two weeks
Method of measurement
positive and negative syndrome scale - positive subscale
2
Description
general improvement
Timepoint
every two weeks
Method of measurement
clinical global impression-Improvement
3
Description
general functioning
Timepoint
baseline and endpoint
Method of measurement
children's global assessment scale
4
Description
extrapyramidal side effects
Timepoint
weeks 1,2,4,6
Method of measurement
simpson-angus extrapyramidal side effects scale, barnes akathisia scale, abnormal involuntary movement scale
5
Description
other side effects
Timepoint
weeks 1, 2, 4, 6
Method of measurement
side effects checklist
Intervention groups
1
Description
Intervention: lithium plus quetiapine up to 600 mg
Category
Treatment - Drugs
2
Description
control: lithium plus risperidone up to 6mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Child and Adolescent psychiatric unit at Razi Psychiatric hospital
Full name of responsible person
Nastaran Habibi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nastaran Habibi
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nastaran Habibi
Position
Assisstant professor/child and adolescent psychiatrist
Other areas of specialty/work
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Fax
Email
na.habibi@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nastaran Habibi
Position
Assisstant professor/child and adolescent psychiatrist
Other areas of specialty/work
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Postal code
Phone
+98 21 2218 0083
Fax
Email
na.habibi@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Nastaran Habibi
Position
Assisstant professor/child and adolescent psychiatrist
Other areas of specialty/work
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Postal code
Phone
+98 21 2218 0083
Fax
Email
na.habibi@uswr.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)