Evaluation of the efficacy of oral and injectable levotiracetam bipolar patients
Design
The clinical trial without a control group, with randomized parallel intervention groups, simple randomization using closed envelopes and is a single-phase phase 3 in which 40 eligible patients will be assigned.
Settings and conduct
Patients with bipolar disorder in the mania phase who refer to Ibn Sina Hospital in Mashhad during the study will be included in the study if they are eligible and will be studied randomly in two intervention groups. This study will be without a control group. The study will be performed single blind so only the analyzer is unaware of the patient's group.
Participants/Inclusion and exclusion criteria
Patients with bipolar disorder in the mania phase
The patient has no other psychiatric disorder or problem.
Exclusion criteria:The patient has not received shock therapy during the past year. pregnancy and breastfeeding.
Intervention groups
In this study, we will have two intervention groups. Without the control group, in the first group, levotiracetam is diluted in 500 mg per 100 ml of normal saline, dextrose or ringer. It is injected every 12 hours for 15 minutes and given for 7 days, then for Oral levotiracetam treatment will be continued for another 7 days, and in the second intervention group, 500 mg oral levotiracetam is given to bipolar patients every 12 hours for 14 days.
Main outcome variables
A) The score of cognitive function using the Stroop questionnaire before and after the intervention; (B) the Intensity of mania using the YMRS (Young Mania Rating Scale) questionnaire before and after intervention. Secondary consequence: None
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N39
Registration date:2021-07-31, 1400/05/09
Registration timing:registered_while_recruiting
Last update:2021-07-31, 1400/05/09
Update count:0
Registration date
2021-07-31, 1400/05/09
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of the efficacy oral levetiracetam and injection levetiracetam in the acute mania in bipolar disorders
Public title
Evaluation the effect of levothiracetam in bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has no other psychiatric disorder or problem.
Patients with bipolar disorder in the mania phase between 18 to 40 years old
Exclusion criteria:
shock therapy during the past year.
Pregnancy and breastfeeding
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study only analyzer, the one who analyzes the outcome, is not aware of the group of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreishi building
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.190
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
Intensity of mania
Timepoint
At the beginning of the study (before the intervention) and after the treatment period
Method of measurement
YMRS (Young Mania Rating Scale) questionnaire
2
Description
Cognitive function
Timepoint
At the beginning of the study (before the intervention) and after the treatment period
Method of measurement
Stroop Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, levotiracetam is diluted at a dose of 500 mg per 100 ml of normal saline, dextrose or ringer. It is injected every 12 hours for 15 minutes and given for 7 days, then oral levotiracetam treatment will be continued for another 7 days.
Category
Treatment - Drugs
2
Description
Intervention group: In the second intervention group, oral levothiracetam 500 mg every 12 hours for 14 days is given to bipolar patients
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital
Full name of responsible person
Ali Akhoond poor Mantegh
Street address
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2709
Email
Manteghia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Akhoond poor Manteghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2709
Email
Manteghia@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Akhoond poor Manteghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2709
Email
Manteghia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Akhoond poor Manteghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91959 83134
Phone
+98 51 3711 2709
Email
Manteghia@mums.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