To assess the effect of levetiracetam versus placebo on the clinical signs of in bipolar patients in the manic episode
Design
This is a double-blind randomized clinical trial, phase II, in which 72 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The bipolar patients in manic episode who will refer to Sina Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 16 to 65 years,
Bipolar disorder in the manic phase,
Young score ≥20
Exclusion criteria:
Bipolar disorder in the depressive phase
Intervention groups
Intervention group:
Standard treatment plus tablet levetiracetam 250 mg three times daily for 28 days
Control group:
Standard treatment plus tablet placebo three times daily for 28 days
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2020-10-01, 1399/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of levetiracetam versus placebo on the clinical signs of in bipolar patients in the manic episode: a double-blind randomized clinical trial
Public title
Effect of levetiracetam versus placebo on the clinical signs of in bipolar patients in the manic episode
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 16 to 65 years,
Bipolar disorder in the manic phase,
Young score ≥20
Exclusion criteria:
Bipolar disorder in the depressive phase
Age
From 16 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions Thus, the trial will be run as triple blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.UMSHA.REC.1398.336
Health conditions studied
1
Description of health condition studied
Bipolar patients in the manic episode
ICD-10 code
F31.2
ICD-10 code description
Bipolar disorder, current episode manic severe with psychotic features
Primary outcomes
1
Description
Clinical signs
Timepoint
Before the intervention and 14 and 28 days after that
Method of measurement
Using the Young Mania Rating Scale (YMRS)
2
Description
Sleep quality
Timepoint
Before the intervention and 14 and 28 days after that
Method of measurement
Using the Pittsburgh Standard Questionnaire
3
Description
Cognitive function
Timepoint
Before the intervention and 14 and 28 days after that
Method of measurement
Using the Montreal Cognitive Assessment (MoCA)
Secondary outcomes
1
Description
Gastric complications
Timepoint
28 days after the intervention
Method of measurement
By history taking
Intervention groups
1
Description
Intervention group: Standard treatment plus tablet levetiracetam 250 mg three times daily for 28 days
Category
Treatment - Drugs
2
Description
Control group: Standard treatment plus tablet placebo three times daily for 28 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan City
Full name of responsible person
Dr Aziz Sharifi
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
azizsharifi91@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Aziz Sharifi
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
azizsharifi91@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ahmadpanah
Position
Clinical Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
m1ahmad2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available