Gabapentin as a combination treatment with lithium in adolescents with bipolar disorder: a double- blind, randomized, placebo-controlled clinical trial
There are some studies about the role of Gabapentin in the treatment of bipolar disorder in adults. So this study is designed to investigate the efficacy of combined Gabapentin and lithium in youths with bipolar disorder.
Method: In a 8 week , double – blind clinical trial, 31 adolescents with a diagnosis of bipolar disorder are randomized into treatment with lithium plus Gabapentin (n=16) or lithium plus placebo (n=15) . The primary outcome measure is young mania rating scale score. Anxiety and depression will be measured biweekly with Hamilton rating scale and Beck depression inventory. Weight and side effects also are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010172000N4
Registration date:2010-10-20, 1389/07/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-20, 1389/07/28
Registrant information
Name
Rozita Davari Ashtiani
Name of organization / entity
Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 1023
Email address
rodavari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Behavioral sciences research center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2007-12-22, 1386/10/01
Expected recruitment end date
2009-04-19, 1388/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Gabapentin as a combination treatment with lithium in adolescents with bipolar disorder: a double- blind, randomized, placebo-controlled clinical trial
Public title
Gabapentin in bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1)10 -17 years of age 2) score more than 20 in Young Mania Rating Scale (YMRS, Yongstorm , et al, 2003) 3)not being on any psychiatric medication for at least two weeks prior to entry into this trial 4) signing a written informed consent. Exclusion criteria: 1) any significant medical illness, 2) IQ lower than70, 3) meeting criteria for substance dependence and abuse in the month before trial
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:
31
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
Shahid Beheshti university of Medical Sciences, Behavioral Sciences research Center
Street address
Imam Hossein Hospital, Shahid Madani st,Tehran
City
Tehran
Postal code
Approval date
2009-02-02, 1387/11/14
Ethics committee reference number
5949
Health conditions studied
1
Description of health condition studied
bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
mania severity
Timepoint
before intervention and every two weeks
Method of measurement
Young Mania ratin Scale
Secondary outcomes
1
Description
anxiety severity
Timepoint
before intervention and every two weeks
Method of measurement
Hamilton rating scale
2
Description
depression severity
Timepoint
before intervention and every two weeks
Method of measurement
Beck Depression Inventory
3
Description
side effects
Timepoint
on weeks 2,4,6,8
Method of measurement
side effects checklist
Intervention groups
1
Description
Intervention: lithium at doses producing a serum concentration of 0.8-1 meq/l + GBP with a target daily dose of 400mg/day
Category
Treatment - Drugs
2
Description
Control: lithium at doses producing a serum concentration of 0.8-1 meq/l + placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zahiroddin, Head of the center, professor of psychiatry
Street address
Imam Hossein Hospital, Shahid Madani st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical 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
Shahid Beheshti University of Medical sciences
Full name of responsible person
Rozita Davari-Ashtiani
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Hossein Hospital, Shahid Madani st
City
Tehran
Postal code
Phone
+98 21 7755 1023
Fax
Email
rodavari@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rozita Davari-Ashtiani
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Hossein Hospital, Shahid Madani st
City
Tehran
Postal code
Phone
+98 21 7755 1023
Fax
Email
rodavari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Rozita Davari-Ashtiani
Position
Assistant professor
Other areas of specialty/work
Street address
Imam Hossein Hospital, Shahid Madani st
City
Tehran
Postal code
Phone
+98 21 7755 1023
Fax
Email
rodavari@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)