The effect and no effect of augmentation of Gabapentin and Memantine with Selective Serotonin Reuptake Inhibitors (SSRIs) in treatment of patients with Obsessive Compulsive Disorder (OCD).
This study will be done to effect and no effect of augmentation of Gabapentin and Memantine with Selective Serotonin Reuptake Inhibitors (SSRIs) in treatment of patients with Obsessive Compulsive Disorder (OCD). The present research is a double blind clinical trial. The study sample population is consist of all patients referring to the addiction treatment center of Farabi Hospital in Kermanshah, which 75 of them will be selected by census method, and in accidental method in three groups of 25 will be replaced and Obsessive-compulsive Scale Yale - Brown (YBOCS) will be distributed among them. The first group, SSRI drugs included fluoxetine with placebo, the second group SSRI drugs with Gabapentin and the third group SSRI drugs with Memantine that each will receive daily for 8 weeks. SSRI drugs with dose of 20 mg, Gabapentin with dose of 150 mg and Memantine with dose of 5 mg will start. And in the fourth week which will be re-examined if the dissatisfaction of patients in reducing the symptoms Fluoxetine dose can be 40 to 60 mg and dose of Gabapentin 600 to 900 mg and Memantine to 10 mg will be increased. The questionnaire will be re-distributed among three groups at the first, 4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder will be measured. Inclusion criteria included a diagnosis of obsessive-compulsive disorder according to the DSM-5 and a history of drug allergy to SSRI's, Memantine or Gabapentin were Exclusion criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062623705N6
Registration date:2016-07-03, 1395/04/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-03, 1395/04/13
Registrant information
Name
Mostafa Alikhani
Name of organization / entity
Kermanshah University of Medical Sciences - Substance Abuse Prevention Research Center
Country
Iran (Islamic Republic of)
Phone
+98 838264513
Email address
mo.alikhani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect and no effect of augmentation of Gabapentin and Memantine with Selective Serotonin Reuptake Inhibitors (SSRIs) in treatment of patients with Obsessive Compulsive Disorder (OCD).
Public title
The effect of augmentation of Gabapentin and Memantine with Selective Serotonin Re uptake Inhibitors (SSRIs) in treatment of patients with Obsessive Compulsive Disorder (OCD).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of obsessive-compulsive disorder according to the DSM-5 by psychologist; patients that their first reference for treatment or at least one month from cutting drug treatment is passed; Age range 20-40 years.
Exclusion criteria: History of organic disease Seizures, diabetes, liver or kidney failure, hypothyroidism; Concomitant use of cardiac medications, Blood pressure, hormones, thyroid; Having other major psychiatric disease and substance abuse; Medical allergy to SSRI, Memantine with Gabapentin; Unwillingness participate in the study; Require hospitalization or receive ECT.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
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
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
kums.rec.1395.86
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
obsessive-compulsive disorder
Timepoint
The beginning of the study (baseline), week four and end of the study (week eight)
Method of measurement
Based on the severity of obsessive-compulsive disorder
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group 1, the participant will receive a SSRI drugs with Memantine (SSRI with a dose of 20 mg, Memantine 5 mg) daily. then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder will be measured
Category
Treatment - Drugs
2
Description
In the control group, the participant will receive a SSRI drugs include Fluoxetine with placebo(Fluoxetine40 to 60 mg ) daily,then the questionnaire will be re-distributed at the baseline, 4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder will be measured.
Category
Placebo
3
Description
In the experimental group 2, the participant will receive a SSRI drugs with Gabapentin (SSRI with a dose of 20 mg, Gabapentin150 mg) daily. then questionnaire will be redistributed at baseline,4 weeks later, and at the end of the study (8 weeks after the start of the study), and the severity of obsessive-compulsive disorder will be measured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Dr. Jalal Shakeri
Street address
Isar square, Farabi Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences , Kermanshah Univers
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences , Kermanshah Univers
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Haniyeh Gharehbaghi
Position
Psychiatrist
Other areas of specialty/work
Street address
Isar square, Farabi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3827 6683
Fax
Email
b.rahami2556@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Psychiatrist
Other areas of specialty/work
Street address
Isar square, Farabi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3826 4513
Fax
Email
vfarnia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Haniyeh Gharehbaghi
Position
Psychiatrist
Other areas of specialty/work
Street address
Isar square, Farabi Hospital
City
Kermanshah
Postal code
Phone
+98 83 3827 6683
Fax
Email
b.rahami2556@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)