Evaluation of the effect of agomelatin on patients with resistant obsessive compulsive disorder
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 60 patients. NCSS (Number Cruncher statistical system) software and block random method are used to randomize the study.
Settings and conduct
Sixty patients with obsessive-compulsive disorder who have been referred to Ibn Sina Psychiatric Hospital(Shiraz, Iran) will be included in the study during 2020. Physicians, patients, and drug deliverer will blind to the allocation of intervention. It should be noted that the drugs' containers is the same. Additionally, placebo tablet is similar to agomelatine tablet regarding the color and shape
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with refractory obsessive-compulsive disorder whose have Y-BOCS questionnaire score is higher than 15; have no other psychiatric disorder.
Exclusion criteria: pregnancy; use of the concomitant psychotherapy.
Intervention groups
Intervention group: 25 mg of agomelatine tablets per night + sertraline 100 mg daily for 12 weeks.
Control group: placebo tablets per night+ sertraline 100 mg daily for 12 weeks
Main outcome variables
Severity of obsession based on Y-BOCS questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190726044339N3
Registration date:2020-12-23, 1399/10/03
Registration timing:registered_while_recruiting
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Seyed Hamdollah Mosavat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 4105
Email address
hamdi_88114@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of Agomalatin and Placebo on symptoms of obsession in resistant obsessive compulsive disorder patients
Public title
The effect of Agomalatin on resistant obsessive compulsive disorder patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with resistant obsessive-compulsive disorder who have not taken any medication for 3 months before the start of the study
Score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) above 15
Exclusion criteria:
Having other psychiatric disorder
Pregnancy and lactation
Having Hepatic disorder
Receive concomitant psychotherapy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will enroll participants based on convenience sampling method. NCSS software (Number Cruncher Statistical System) and block randomization method will be used for randomization in the study. In the block randomization method, participants will categorize into 6 blocks (AABB, ABAB, BBAA, BABA, ABBA, BAAB), each block containing 4 participants. In this study, "A" will assign to the drug group and "B" to the placebo group, for example: in the "ABAB" block, the first person enters the drug group, the second person enters the placebo group, the third person enters the drug group, and the fourth person enters the placebo group. Thus, all eligible participants will randomly be assigned to one of the study arms according to the randomization list.
Blinding (investigator's opinion)
Double blinded
Blinding description
Physicians, patients, and drug deliverer will blind to the allocation of intervention. It should be noted that the drugs' containers is the same. Additionally, placebo pill is similar to agomelatin pill regarding the color and shape
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Ibn Sina Hospital; Hafez street
City
Shiraz
Province
Fars
Postal code
7134845794
Approval date
2020-04-16, 1399/01/28
Ethics committee reference number
IR.SUMS.MED.REC.1399.039
Health conditions studied
1
Description of health condition studied
obsessive-compulsive disorder (OCD)
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsession severity
Timepoint
At the beginning of the study and at the 12th week
Method of measurement
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: agomelatin 25 mg one tablet per night with 100 mg of sertraline daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: One placebo tablet every night with a daily intake of 100 mg of sertraline for twelve weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Psychiatric Hospital
Full name of responsible person
Amir Bazafshan
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3228 9601
Email
hamdi_88114@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Bazrafshan
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
71466 76549
Phone
+98 71 3228 9604
Email
hamdi_88114@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Nejati
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 71 3228 9601
Email
hamdi_88114@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Bazrafshan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
71466 76549
Phone
+98 917 309 9835
Email
Bazrafshana@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Nejati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
71466 76549
Phone
+98 71 3228 9601
Email
hamdi_88114@yahoo.com
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