-Evaluating the effect of Levetiracetam on the duration of hospital stay and appropriate management of patients with symptoms of Benzodiazepine withdrawal syndrome
-Assessing the severity of symptoms in Benzodiazepine withdrawal syndrome
-Evaluating the dose of Clonazepam needed in patients experiencing Benzodiazepine withdrawal syndrome, after taking Levetiracetam and after taking placebo, and comparing the two of them
-Mitigating the adverse effects and troubles caused by Benzodiazepine withdrawal
Design
This is a single-blind, parallel clinical trial, with two groups consisting of a drug or main group and a placebo or control group. Two-Digit randomizing table was used.
Settings and conduct
This clinical trial takes place in Roozbeh hospital, and is supervised by a clinical pharmacist, a neurologist and a pharmacy student.The drugs are given to patients in the ward by the nurses and the patients are not aware of their groups. CIWA-B questionnaire is filled by one of the supervisors.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who have been taking Benzodiazepines for at least 3 months and have not ceased using them for more than a month
Exclusion Criteria: Patients diagnosed with acute and major psychological disorders, schizophrenia, epilepsy, or concurrent neurological disorders, e.g. Multiple Sclerosis
Patients with a history of taking Levetiracetam or receiving concurrent Gabapentin or Carbamazepine in the last six months
Patients younger than 15 years of age
Allergic reactions to Levetiracetam or its excipients
Severe adverse drug reactions
Intervention groups
Prescribing 500 milligrams of Levetiracetam in the drug group, for 2 weeks, 2 times a day
Prescribing placebo in the control group, for 2 weeks, 2 times a day
Main outcome variables
Duration of hospitalization-CIWA-B sum of scores-Dose of the Clonazepam needed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200701047979N1
Registration date:2020-07-20, 1399/04/30
Registration timing:registered_while_recruiting
Last update:2020-07-20, 1399/04/30
Update count:0
Registration date
2020-07-20, 1399/04/30
Registrant information
Name
Sheida Javid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 7260
Email address
sh.javid@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-28, 1399/04/08
Expected recruitment end date
2021-06-29, 1400/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Levetiracetam on Benzodiazepine Withdrawal Syndrome in Comparison with Placebo
Public title
Effect of Levetiracetam on Benzodiazepine Withdrawal Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had been taking Benzodiazepines for at least three months, and have not discontinued them for more than one month.
Exclusion criteria:
Patients diagnosed with acute and major psychological disorders, schizophrenia, epilepsy, or concurrent neurological disorders, e.g. Multiple Sclerosis
Patients with a history of taking Levetiracetam or receiving concurrent Gabapentin or Carbamazepine in the last six months
Patients younger than 15 years of age
Allergic reactions to Levetiracetam or its excipients
Severe adverse drug reactions
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling takes place when a patient is referred to the emergency room of Roozbeh hospital, and he/she meets the study’s inclusion and exclusion criteria. For sampling allocation, permuted block randomization technic was used to prepare a randomizing table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients participating in the study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
VCR, 6th Floor, Tehran University of Medical Sciences Central Building, Ghods Street, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2020-03-07, 1398/12/17
Ethics committee reference number
IR.TUMS.TIPS.REC.1398.212
Health conditions studied
1
Description of health condition studied
Benzodiazepine Withdrawal Syndrome
ICD-10 code
T42.4X5
ICD-10 code description
Adverse effect of benzodiazepines
Primary outcomes
1
Description
Sum of Scores for CIWA-B Questionnaire
Timepoint
At benzodiazepine cessation and before taking Levetiracetam, then 2 weeks after taking Levetiracetam
Method of measurement
CIWA-B Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: patients in this group are given placebo 2 times a day for 2 weeks-The placebos are the exact physical replica of Levetiracetam tablets manufactured by Abidi Pharmaceutics. All the excipients are chemically the same and only the API (Active Pharmaceutical Ingredient) is removed.
Category
Placebo
2
Description
Intervention group: patients in this group are given 500 milligrams of Levetiracetam 2 times a day for 2 weeks.-Both Levetiracetam tablets and the placebos are manufactured by Abidi Pharmaceutics.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Psychiatric Hospital
Full name of responsible person
Sheida Javid
Street address
Roozbeh Hospital, Lashkar Crossroad, South Karegar Street, District 11, Tehran
City
Tehran
Province
Tehran
Postal code
1591413337
Phone
+98 21 5541 9151
Email
sh.javid@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niayesh Mohebbi
Street address
VCR, 6th Floor, Tehran University of Medical Sciences Central Building, Ghods Street, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3639
Email
research@tums.ac.ir
Web page address
http://research.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
Sheida Javid
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Tehran University of Medical Sciences, 16 Azar Street, Enghelab, Tehran
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8888 7260
Fax
Email
sh.javid@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niayesh Mohebbi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
School of Pharmacy, Tehran University of Medical Sciences, 16 Azar Street, Enghelab Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
0098 21 64120
Email
nmohebbi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sheida Javid
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Tehran University of Medical Sciences, 16 Azar Street, Enghelab, Tehran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8888 7260
Fax
Email
sh.javid@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Changes in CIWA-B total scores
When the data will become available and for how long
starting 3 months after publication
To whom data/document is available
Available to industrial or clinical pharmacists, and also to neurologists
Under which criteria data/document could be used
Please contact us beforehand.
From where data/document is obtainable
Sheida Javid via sh-Javid@student.tums.ac.ir or sh.javid@yahoo.com
What processes are involved for a request to access data/document