Comparison of the efficacy of adding clonidine to SSRI and treating patients with SSRI alone in patients with treatment-resistant obsessive compulsive disorder
Determine the efficacy of adding clonidine to the treatment of obesity-resistant obesity disorders
Design
Clinical trial with parallel control group, double blind, randomized phase 4 with 30 patients
Settings and conduct
Patients with obsessive-compulsive disorder, based on Clinical Neuropsychiatry 2013, who have been treated with a maximum dose of SSRI or clomipramine for at least 12 weeks, with a scoring scale of more than 16 (YBOCS) and clinics Obsessions at the Noor Hospital and the Psychiatric Clinic will add. 30 patients will be enrolled in this study. In this method, patients will be divided into two groups of intervention and placebo in a randomized block. In this study, patients and therapist are unaware of the drug. In the intervention group, clonidine tablets start with a dose of 0.1 mg per night, and 0.2 mg daily are administered to a maximum of 1 mg per day. placebo will be given to control group. In both groups SSRIs or clomipramines will continue with the previous dose and the YBOCS OCD will be completed at the end of the week 4-8 and 12.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1-The presence of obsessive-compulsive disorder criteria based on DSM-V-TR
2. Receive at least 12 weeks with a maximum dose of a serotonergic drug (SSRI or clomipramine)
3. moderate or severe symptoms on a scale of obsessive - compulsive Yale-Brown (YBOCS) to score more than 16
۴. No initial diagnosis of psychiatric disorders and mood disorder (Bipolar or MDD)
Exclusion Criteria:
1- Pregnancy at each stage of the research
2- Cancellation of participation in the study at each stage of the research
Intervention groups
Iintervention group, patients initially opened a dose of 0.1 mg of clonidine per night, and each week, 0.2 mg is added to this dose to reach 1 mg / day, and in Control group patients will use placebo.
Main outcome variables
Obsessive-Compulsive Scale YBOCS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110918007582N2
Registration date:2018-12-01, 1397/09/10
Registration timing:prospective
Last update:2018-12-01, 1397/09/10
Update count:0
Registration date
2018-12-01, 1397/09/10
Registrant information
Name
shahla akuchekian
Name of organization / entity
Isfahan university
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2127
Email address
akuchekian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of adding clonidine to SSRI and treating patients with SSRI alone in patients with treatment-resistant obsessive compulsive disorder
Public title
Evaluation of Clonidine Therapeutic Effect Added to Usual Treatment in Refractory Obsessive –Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of obsessive-compulsive disorder criteria based on DSM-V-TR
Receive at least 12 weeks with a maximum dose of a serotonergic drug (SSRI or Clomipramine)
Moderate to severe symptoms based on the obsessive-compulsive- Yerobyll-Brown scale (YBOCS) with a score of more than 16
Obtain informed consent from the patient
No initial diagnosis of psychiatric disorders and mood disorder (bipolar or MDD)
Absence of drug use or dependence
There is no uncontrolled physical illness (such as diabetes, blood pressure, etc.)
There is no previous history of Clonidine use
Lack of pregnancy and lactation or planning for pregnancy during the study
There is no seizure disorder
No suicide attempt
Not taking beta-blocker
Failure to receive synchronous psychological intervention
Exclusion criteria:
Cancellation of participation in the study at each stage of the research
Pregnancy at each stage of the research
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using a random number table for people with obsessive-compulsive disorder. The random numbers and numbers are extracted by the computer and for allocation concealment unique code will be use.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients do not know about their treatment, and medications are given in asymptomatic packagings to clinicians not to be aware about the pateint's treatment during the course.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciense
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.MUI.MED.REC.1397.085
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
OCD Scale changes with YBOCS questionnaire
Timepoint
Before the intervention and at the end of 4-8-12 weeks
Method of measurement
Yale Brown Obsessive-Compulsive Scale (YBOCS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Clonidine tablets start with a dose of 0.1 mg once a night, and weekly (based on patient tolerance) 0.2 mg will add to reach a maximum of one mg per day. This dose is based on the administration of clonidine in other psychiatric disorders
Category
Treatment - Drugs
2
Description
Control group: Will use placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Noor Hospital
Full name of responsible person
Dr Shahla Akuchekian
Street address
Isfahan Province, Isfahan, Ostandari Street
City
Isfahan
Province
Isfehan
Postal code
5138663134
Phone
+98 31 3222 2127
Email
akuchekian@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shahryar Moazeni
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
5138663134
Phone
+98 31 3222 2127
Email
akuchekian@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shahla Akuchekian
Position
Psychaitric Assistant Profesor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isfahan university
City
Isfahan
Province
Isfehan
Postal code
5138663134
Phone
+98 31 1222 2127
Fax
+98 31 2222 2145
Email
akuchekian@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla Akuchekian
Position
Psychaitric Assistant Profesor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isfahan university
City
Isfahan
Province
Isfehan
Postal code
5138663134
Phone
+98 31 1222 2127
Fax
+98 31 2222 2145
Email
akuchekian@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla Akuchekian
Position
Psychaitric Assistant Profesor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Isfahan university
City
Isfahan
Province
Isfehan
Postal code
5138663134
Phone
+98 31 1222 2127
Fax
+98 31 2222 2145
Email
akuchekian@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be available.
When the data will become available and for how long
Access will begin immediately after the article is publish.
To whom data/document is available
Data will be available to all people.
Under which criteria data/document could be used
All the necessary analyzes can be done and there are no specific conditions for access.
From where data/document is obtainable
Send applicant to Dr. Akuchekian, email her at akuchekian@med.mui.ac.ir
What processes are involved for a request to access data/document
In the shortest time it will be available to the applicant.