Comparison of treatment effect of Agomelatine plus Sertraline with Placebo and Setraline on OCD patients
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment. Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks. To do study with concealment, table of block will be used by one of researchers, other than interviewer and who assess patients in follow-up visits, to write number of each participants on box of additional drugs. Therefore, all of patients, interviewer and who assess patients in follow-up visits will be unaware if each number belongs to which groups.
Settings and conduct
OCD outpatients who come to psychiatric clinics of Iran University of Medical Sciences will be recruited.
Participants/Inclusion and exclusion criteria
Patients who meet DSM-5 criterion for OCD and they achieve more than 21 for Yale-Brown Obsessive Compulsive Scale are suitable for study. They should be 18-65 year old and sign consent form.
They should not be treated by any psychiatric interventions for last 6 weeks. If they show any other important mental condition or suicidal thought, neurological deficit, will exclude from study. They will be evaluated for cardiac, liver, kidney, pregnancy, lactation and mental retardation before entrance and any mentioned conditions will cause exclusion from study.
Intervention groups
Agomelatine plus Setraline and Placebo plus Sertraline
Main outcome variables
Severity of obsessive-compulsive disorder
General information
Reason for update
Acronym
OCD
IRCT registration information
IRCT registration number:IRCT20170123032145N5
Registration date:2020-07-14, 1399/04/24
Registration timing:prospective
Last update:2020-07-14, 1399/04/24
Update count:0
Registration date
2020-07-14, 1399/04/24
Registrant information
Name
Mohammadreza Shalbafan
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1665
Email address
shalbafan.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Agomelatine as Adjunctive Therapy in Obsessive Compulsive Disorder A Double-blind,Placebo-controlled,Randomized Trial
Public title
Agomelatine for treatment of Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who meet DSM-5 criterion for OCD
Achieve more than 21 for Yale-Brown Obsessive Compulsive Scale
Age: 18-65 year old
Sign consent form
Exclusion criteria:
They should not be treated by any psychiatric intervention for last 6 weeks.
If they show any other important mental condition or suicidal thought, neurological deficit, will exclude from study.
They will be evaluated for cardiac, liver, kidney, pregnancy, lactation and mental retardation before entrance and any mentioned conditions will cause exclusion from study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be used in this trial based on balance block randomization and by 4:1 blocks
Blinding (investigator's opinion)
Triple blinded
Blinding description
To do study with concealment, table of block will be used by one of researchers, other than interviewer and who assess patients in follow-up visits, to write number of each participants on box of additional drugs. Therefore, all of patients, interviewer and who evaluates patients in follow-up visits will be unaware if each number belongs to which groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-04-16, 1399/01/28
Ethics committee reference number
IR.IUMS.REC.1399.101
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Severity of obsessive-compulsive disorder
Timepoint
Weeks: 0, 4, 8 and 12
Method of measurement
Yale-Brown Obsessive Compulsive Scale(YBOCS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sertraline(Tab) up to 200 mg/day plus Agomelatine (Tab) 25 mg daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Sertraline(Tab) up to 200 mg/day plus placebo(Tab) daily for 12 weeks