Additive Effect of Botulinum Toxin on Conventional Treatment in Bipolar disorder, current episode depression
Design
A randomized clinical trial with parallel control group, double blind; Phase 2-3, on 70 patients; randomization is performed by using block randomization.
Settings and conduct
This study is performed in Farshchian Hospital in Hamadan
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with diagnosed bipolar depression based on DSM-5 and MADRS score equal to or more than 7.
Exclusion criteria: history of Botox injections in the past year; contraindication to receiving botulinum type A.
Intervention groups
In the intervention group: injection of 48 units in women and 64 units in men Botulinum toxin type A from support brand soluble in 2 cc of normal saline in 8 points glabellar & forehead.
Control group: normal saline 9% with a volume equal to the intervention group at 8 points glabellar & forehead.
Main outcome variables
Compare rates of depression before and after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N7
Registration date:2021-01-18, 1399/10/29
Registration timing:registered_while_recruiting
Last update:2021-01-18, 1399/10/29
Update count:0
Registration date
2021-01-18, 1399/10/29
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Additive Effect of Botulinum Toxin on Conventional Treatment in Bipolar disorder current episode depression
Public title
Botulinum type A treatment of depressive episode in bipolar patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosed bipolar depression based on DSM-5
MADRS score equal to or more than 7
Exclusion criteria:
History of Botox injections in the past year.
Contraindication to receiving botulinum type A.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
35
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to the intervention and control groups using block randomization. The patients will be randomly assigned to the intervention and control groups using block randomization; arrangement of the randomization process: 1); determining the volume of each block (quadruple blocks) 2); preparing the list of the blocks and assigning a number (between 1 and 6 ) to each of them 3); choosing random numbers between 1 and 6; 4) defining the treatment assignment list.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the examining physician will not be aware of the patient's type of drug treatment, so the study will be double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
1960-05-24, 1339/03/03
Ethics committee reference number
IR.UMSHA.REC.1399.223
Health conditions studied
1
Description of health condition studied
Bipolar II disorder
ICD-10 code
F31.81
ICD-10 code description
Bipolar II disorder
Primary outcomes
1
Description
Depression rate
Timepoint
At the start of intervention- After intervention
Method of measurement
Hamilton Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: injection of 48 units in women and 64 units in men Botulinum toxin type A from support brand soluble in 2 cc of normal saline in 8 points Glabellar & forehead
Category
Treatment - Drugs
2
Description
Control group: normal saline 9% with a volume equal to the intervention group at 8 points Glabellar & forehead
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Lila Jahangard
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
Jahangard_Li@yahoo.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
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_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
Lila Jahangard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
Jahangard_Li@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Lila Jahangard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
Jahangard_Li@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Lila Jahangard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
Jahangard_Li@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