Evaluation of Memantine effect as adjunctive therapy in patients with treatment-resistant obsessive-compulsive disorder (double-blind, controlled clinical trial)
The aim of this study was to investigate the role of memantine as an augmentation treatment for obsessive-compulsive disorder for patients that have not responded to conventional therapies like antidepressants. In this study, patients between 18 and 40 years, who based on the criteria of DSM-V have obsessive-compulsive disorder, and were at least under 3 months of treatment with antidepressants at the maximum dose and have a score of 21 or above at the standard Yale-Brown Obsessive Compulsive Scale will be evaluated. In this study, 32 patients referred to Golestan hospital that have inclusion criteria and none of exclusion criteria enter the study by block randomization using 3 blocks divided into 2 groups. 16 patients are on drug group and 16 on placebo group. The study is double-blind. Drugs with a dose of 20 mg and placebos with the same appearance (including color, size and design) and identical packaging are given to patients. The response of patients to adjuvant treatment is measured via Yale-Brown Obsessive Compulsive Scale and score of patients is the primary outcome of this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110324853N1
Registration date:2016-01-11, 1394/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-11, 1394/10/21
Registrant information
Name
Leila Kouti
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8379
Email address
kouti-l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Funds allocated for student thesis Doctor of Pharmacy by Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-12-16, 1394/09/25
Expected recruitment end date
2016-05-14, 1395/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Memantine effect as adjunctive therapy in patients with treatment-resistant obsessive-compulsive disorder (double-blind, controlled clinical trial)
Public title
Memantine effect on treatment of drug resistant obsessive obsessive compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with known obsessive compulsive disorder by DSM-V criteria; no other mental disorder; no other systemic disorder such as diabetes,hypertension,hyper and hypo thyroidism ;no alcohol intake and not a drug user; between 18 to 40 years old; the patient should be treated for at least 3 months with an antidepressant at highest dose and have a score of 21 or more in Yale-Brown Obsessive Compulsive Scale test.
exclusion criteria:Pregnancy and nursing; Patients with a history of memantine use; Patients who do not sign the consent form.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Highway, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
IR.AJUMS.REC.1394.314
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
patient's score in Y-BOCS test
Timepoint
before intervention and 8 weeks after the treatment
Method of measurement
Y-BOCS test
Secondary outcomes
1
Description
Side effects
Timepoint
every week for 8 weeks of giving drug or placebo
Method of measurement
the list of memantine adverse effects
Intervention groups
1
Description
Intervention group with active drug
Memantine, 20 mg tablets
one per day for 8 weeks
Category
Treatment - Drugs
2
Description
control group
placebo tablets, one per day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Setareh Razooghi
Street address
Golestan Hospital, Golestan Blvd.
City
Ahvaz
2
Recruitment center
Name of recruitment center
private office of Dr Sayyah
Full name of responsible person
Setareh Razooghi
Street address
Pharmacy School, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology developement
Full name of responsible person
Nader Saki
Street address
Ground floor,Deputy of research and technology developement, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Grant name
پایان نامه دکترای حرفه ای داروسازی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology developement
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
Pharmacy school
Full name of responsible person
Setareh Razooghi
Position
Pharmacy student
Other areas of specialty/work
Street address
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 3373 8379
Fax
Email
setareh_razoughi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmacy School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
Full name of responsible person
Leila Kouti
Position
Clinical pharmacy specialist, Assistant professor
Other areas of specialty/work
Street address
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 3373 8379
Fax
Email
lkouti.pharmacotherapy@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Leila Kouti
Position
Clinical pharmacy specialist, Assistant professor
Other areas of specialty/work
Street address
Pharmacy school, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61337382418
Fax
Email
lkouti.pharmacotherapy@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)