The efficacy of levetiracetam as an adjuvant agent in the treatment of bipolar disorder (mania episode)
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be conducted among adults with moderate to severe mania (BID) attending Roozbeh Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: meeting the DSM-5 criteria for Bipolar Disorder(manic episode); age between 18 and 60 years old; a score of at least 20 points on the Young Mania Rating Scale.
Exclusion criteria: hyper- or hypothyroidism; substance dependence (except for Nicotine or caffeine); IQ lower than 70; lactating or pregnant women; severe hepatic disease.
Intervention groups
The participants will be randomly allocated into two groups. Intervention group (20 persons) will receive levetiracetam (20 mg/kg which will be increased to 50 mg/kg within 4 weeks) and quetiapine ( 100 mg per day which will be increased to 300 mg/ day within 2 weeks) and control group ( 20 persons) will receive quetiapine ( 100 mg per day which will be increased to 300 mg/ day within 2 weeks) and placebo for 6 weeks.
Main outcome variables
Severity of mania
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N117
Registration date:2019-03-15, 1397/12/24
Registration timing:prospective
Last update:2019-03-15, 1397/12/24
Update count:0
Registration date
2019-03-15, 1397/12/24
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-05, 1398/01/16
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Levetiracetam as adjuvant therapy in acute mania : a double blind controlled trial
Public title
Levetiracetam as adjuvant therapy in acute mania
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Meeting the DSM-IV criteria for Bipolar Disorder-manic episode
Age between 18 and 60 years old
A score of at least 20 points on the Young Mania Rating Scale
Exclusion criteria:
Hyper- or hypothyroidism
Substance dependence(except for Nicotine and caffeine)
IQ lower than 70
Lactating or pregnant women
Severe hepatic disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random permuted block
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome raters will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences, Ghods Avn., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-03-08, 1397/12/17
Ethics committee reference number
IR.TUMS.VCR.REC.1397.948
Health conditions studied
1
Description of health condition studied
Bipolar Disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Severity of mania
Timepoint
Baseline and weerks: 2, 4, 6
Method of measurement
by Young Mania Rating Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: tablet quetiapin ( 100 mg/day which will be increased to 300 mg per day within 2 weeks) plus capsule levetiracetam ( 20 mg per kg/day which will be increased to 50 mg/kg/day) as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: tablet quetiapin ( 100 mg/day which will be increased to 300 mg per day within 2 weeks) plus capsule placebo as control group for 6 week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Sreeet
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@tums.ac.ir
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
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof.Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2021 to 2026
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
by citing the resourse
From where data/document is obtainable
Professor Shahin Akhondzadeh
What processes are involved for a request to access data/document