Comparing the clinical response of obsessive-compulsive patients refractory to serotonin reuptake inhibitor regimen with and without lamotrigine; a double-blind placebo controlled study
The 60 patients were entered in this study. Patients were diagnosed with obsessive-compulsive disorder, based on structured clinical interviews by skilled psychiatrist on the basis of the DSM IV TR criteria, and received at least two trimester trials of serotonin reuptake inhibitors while still suffering from a Yale brown obsessive-compulsive score of 21 and higher who were resistant to treatment. Before entering the study, all the patients, their parents or their lawyer sign the informed consent.
The subjects are selected from private clinical psychiatric centers in Rasht and randomized by a computer based program into two groups, each containing 30 patients. Based on the group they are assigned to, the patients receive placebo or Lamotrigine. Both groups receive the same number of identical capsules during the study. Lamotrigine dosage starts at 25 mg daily, which will increase 25 mg each week to reach the target level of 100 mg. Then the dosage will be maintained at 100 mg until the end of the study. Yale Brown Obsessive-Compulsive Scale is checked on days 0, 60 and 90 by a skilled clinical PhD psychologist who performs the whole study in a double-blind method. The duration of the study is 90 days. Finally the changes in the Yale Brown Obsessive- Compulsive Scale on day 90 compared to day zero will be assessed. At last, if any of the patients need any more therapeutic care, it will be provided.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031717045N1
Registration date:2014-10-04, 1393/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-04, 1393/07/12
Registrant information
Name
Seyyed Mohammad Rasool Khalkhali
Name of organization / entity
Guilan university of medical sciences, Shafa hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 2325
Email address
khalkhali@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-04-21, 1395/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the clinical response of obsessive-compulsive patients refractory to serotonin reuptake inhibitor regimen with and without lamotrigine; a double-blind placebo controlled study
Public title
Comparing the clinical response of obsessive-compulsive patients refractory to serotonin reuptake inhibitor regimen with and without lamotrigine; a double-blind placebo controlled study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:OCD diagnosis on axis I based on DSM IV TR; Ages between 16 and 60; Yale Brown Obsessive Compulsive Score of more than 21
Exclusion criteria: Active psychotic disorder such as schizophrenia, psychotic bipolar disorder and major depressive disorder; Major organic disorder; Organic brain disorder; Drug and substance abuse; Mental retardation; Pregnancy and lactation; During psychotherapy
Age
From 16 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee in Research and Technology Branch
Street address
Shahid Beheshti BLVD
City
Rasht
Postal code
Approval date
2014-03-17, 1392/12/26
Ethics committee reference number
1920452601
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive patients
ICD-10 code
F42
ICD-10 code description
The essential feature is recurrent obsessional thoughts or compulsive acts.
Primary outcomes
1
Description
Clinical response is measured by Yale Brown Obsessive Compulsive Scale
Timepoint
The day 0, 60 and 90
Method of measurement
Yale Brown Obsessive Compulsive Scale
Secondary outcomes
empty
Intervention groups
1
Description
Patients in intervention group continue the previous medication, Serotonin Reuptake Inhibitors, all over the study. Intervention group receive capsules containing lamotrigine, starting at 25 mg daily, titrated up to 25 mg weekly to reach the target level of 100 mg at the end of the 4th week. At this point, the dosage will be maintained at the same level until the end of the study, which lasts 90 days.
Category
Treatment - Drugs
2
Description
Patients in the placebo group continue previous medication, Serotonin Reuptake Inhibitors, all over the study. Patients in the placebo group receive one capsule daily. The number, shape and size of the capsules in the placebo group are exactly the same as those in the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Two private psychiatric clinic
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Guilan University of Medical Sciences
Street address
West Shahid Beheshti BLVD
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilln University of Medical Sciences
Full name of responsible person
Setareh Aram
Position
Psychiatric Assistant
Other areas of specialty/work
Street address
Shafa Hospital- 15th street
City
Rasht
Postal code
Phone
+98 13 1666 2325
Fax
Email
Setareh.aramt@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Rasool Khalkhali
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Shafa Hospital- 15th street
City
Rasht
Postal code
Phone
+98 13 1666 2325
Fax
Email
Khalkhali@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Rasool Khalkhali
Position
Assistant Professor of psychiatry
Other areas of specialty/work
Street address
Shafa Hospital- 15th street
City
Rasht
Postal code
Phone
+98 13 1666 2325
Fax
Email
Khalkhali@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)