Comparing the efficacy and side effects of concurrent use of aripiprazole versus placebo with lithium in pediatric patients with acute manic/mixed episodes of bipolar disorder
The aim of this randomized, double-blind study is to compare the efficacy and safety of 6-week use of Aripiprazole and lithium combination versus lithium and placebo in manic/mixed episodes of children and adolescent with bipolar disorder (BD). Atotal of forty patients (between 10-17 years-old) with a diagnosis of BD who receive lithium and meet the study criteria will be randomly assigned to either aripiprazole or placebo group. All participants receive lithium (300 mg 3 or 4 times/day). The patients in the intervention group will receive Aripiprazole (2.5 mg for two days, 5mg after that for 2 days, 10mg for two days and 15 mg/day for the rest of the study) and the others in the control group will receive the same doses of placebo. Bipolar severity will be evaluated by using Young Mania Rating Scale (YMRS), Clinical Global Impression Scale (CGIS) and Children’s Global Assessment Scale (CGAS). Treatment improvements in manic/mixed episodes of BPD will be assessed after 3 and 6 weeks. Laboratory tests including CBC, FBS, TG, Total Cholesterol, Serum Cr, T4 & TSH will be measured at the baseline and after 6 weeks. Additionally, a side-effect checklist will be filled at the baseline as well as at weeks 3 and 6.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108027202N1
Registration date:2011-09-06, 1390/06/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-06, 1390/06/15
Registrant information
Name
Padideh Ghaeli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
pghaeli@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Reseach of Faculty of Pharmacy of Tehran University of Medical Sciences - Sobhan Darou Co. ( for Providing Aripiprazole & Placebo)
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2012-04-29, 1391/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy and side effects of concurrent use of aripiprazole versus placebo with lithium in pediatric patients with acute manic/mixed episodes of bipolar disorder
Public title
Effect of Adding Aripiprazole to Li Therapy in Children & Adolescents with BPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hospitalized Patients, between 10 to 17 years old, diagnosis of BPD based on DSM-IV-TR
Exclusion criteria: Hypersensitivity to Aripiprazole or Lithium, Severe Medical Conditions (cardiovascular disorders, hepatic, renal and thyroid dysfunctions & severe diabetes), Serious Neurological Disorders, Dehydration, Ketoacidosis, Pregnancy, Lactation, MR patients
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Pharmaceutical Sciences Research Center of Tehran University of Medical Sciences
Street address
Faculty of Pharmacy- Tehran University of Medical Sciences-16th Azar Street- Tehran
City
Tehran
Postal code
Approval date
2011-05-17, 1390/02/27
Ethics committee reference number
90-2-27:16-12
Health conditions studied
1
Description of health condition studied
Bipolar Disorder Manic/Mixed phase in Children & Adolescents
ICD-10 code
F30
ICD-10 code description
Manic episode
Primary outcomes
1
Description
efficacy
Timepoint
Baseline, 3 and 6 weeks after the treatment
Method of measurement
Young Mania Rating Scale, CGI-Improvement and CGAS Scales
Secondary outcomes
1
Description
changes in blood glucose level
Timepoint
Before Entering the Study and 6 Weeks after treatments
Method of measurement
FBS Laboratory test
2
Description
changes in Triglycerides Fasting level
Timepoint
Before Entering the Study and 6 Weeks after treatments
Method of measurement
TG Laboratory test
3
Description
changes in Total Cholesterol level
Timepoint
Before Entering the Study and 6 Weeks after treatments
Method of measurement
Total Chol. Laboratory test
4
Description
Blood Cells Counting
Timepoint
Before Entering the Study and 6 Weeks after treatments
Method of measurement
CBC Laboratory test
5
Description
changes in serum creatinine level
Timepoint
Before Entering the Study and 6 Weeks after treatments
Method of measurement
Serum Cr. Laboratory test
6
Description
changes in T4, TSH levels
Timepoint
Before Entering the Study and 6 Weeks after treatments
Method of measurement
Thyroid function test
7
Description
weight changes
Timepoint
Before Entering the Study and 6 Weeks after treatments
Method of measurement
measuring weight by balance
8
Description
other side effects of treatments
Timepoint
after 3 and 6 weeks of treatment
Method of measurement
Side Effect Check List
Intervention groups
1
Description
Intervention group: day 1 to 3: Lithium with usual dose (300mg TDS or QID po) +2.5mg Aripiprazole once daily po - day 3 to 5: Lithium with usual dose (300mg TDS or QID po) + 5mg Aripiprazole once daily po - day 5 to 7: Lithium with usual dose (300mg TDS or QID po) + 10mg Aripiprazole once daily po - day 7 to the end of Study: Lithium with usual dose (300mg TDS or QID po) + 15mg Aripiprazole once daily po - unless dose adjustments required. The patients will receive Lorazepam po PRN or Halopridol Inj PRN if needed.
Category
Treatment - Drugs
2
Description
Control Group: day 1 to 3: Lithium with usual dose (300mg TDS or QID po) + 2.5mg Placebo once daily po - day 3 to 5: Lithium with usual dose (300mg TDS or QID po) + 5mg Placebo once daily po - day 5 to 7: Lithium with usual dose (300mg TDS or QID po) + 10mg Placebo once daily po – day 7 to the end of the study: Lithium with usual dose (300mg TDS or QID po) + 15mg Placebo once daily po -unless dose adjustments required. The patients will receive Lorazepam po PRN or Halopridol Inj PRN if needed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Children & Adolescents Psychiatry of Imam Hussein Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Department of Children & Adolescents Psychiatry of Rouzbeh Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Reseach of Faculty of Pharmacy
Street address
Faculty of Pharmacy-Tehran University of Medical Sciences-16th Azar Street-Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Sobhan Darou Co.
Full name of responsible person
Dr Farhat
Street address
No. 295- Dr Fatemi Street- Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sobhan Darou Co.
Proportion provided by this source
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
Faculty of Pharmacy of Tehran University of Medical Scienses
Full name of responsible person
Doctor Padideh Ghaeli
Position
Associate Professor of Clinical Pharmacy,Faculty of Pharmacy of Tehran University of Medical Sciense
Other areas of specialty/work
Street address
Department of Clinical Pharmacy-Faculty of Pharmacy-Tehran University of Medical Scienses-16th Azar Street-Tehran