The effect of memantine with a dose of 20 mg for the treatment of obsessions in bipolar patients with a fixed regimen of quetiapine and lithium
Design
A controlled, parallel-group, double-blind, randomized clinical trial on 46 patients.
Settings and conduct
It is performed in a double-blind manner in the psychiatry department of Golestan Hospital, Ahvaz. Bipolar patients are divided into two groups of 23 people and treated with 10 mg of memantine. Placebos are assigned to the control group, and after six weeks, the effects and side effects are checked in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 18-65, bipolar patients with obsessive-compulsive comorbidity, and consent of the patient.
Intervention groups
Intervention group: In addition to the routine bipolar treatment, 10 mg (Shefa Daroo Company) memantine tablets as one tablet after a detailed history and confirmation of the patient's obsession.
Control group: In addition to the routine treatment of the bipolar disorder, they will receive a placebo tablet that is similar to memantine in terms of shape, smell, taste, size and colour and is prepared by the Faculty of Pharmacy of Ahvaz University in the same way as the intervention group.
Main outcome variables
Obsession score, side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240601061976N1
Registration date:2024-06-05, 1403/03/16
Registration timing:prospective
Last update:2024-06-05, 1403/03/16
Update count:0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Hamzeh Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 0000
Email address
rostami_h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of memantine with a dose of 20 mg for the treatment of obsessions in bipolar patients with a fixed regimen of quetiapine and lithium
Public title
Investigating the effect of memantine for the treatment of obsessions in bipolar patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18-65
Bipolar patients with obsessive compulsive comorbidity
Consent of the patient's guardian
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with eligibility criteria will be divided into two groups using a randomized block design. An online website (https://www.sealedenvelope.com) generates a random list based on the desired sample size and block size of 4. After creating a list, each patient will be identified with a unique code throughout the study. 23 patients are selected for the intervention group and 23 for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the researcher, and the treatment staff are kept blind, and the drugs are adjusted by a nurse not related to the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Golestan St., Esfand St., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2024-01-06, 1402/10/16
Ethics committee reference number
IR.AJUMS.REC.1402.527
Health conditions studied
1
Description of health condition studied
Bipolar
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Obsession score
Timepoint
Before the intervention, 3, and 6 weeks after the intervention
Method of measurement
According to DSM-5 criteria
2
Description
Side effects of memantine
Timepoint
During the study, 3, and 6 weeks after the intervention
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine bipolar treatment, 10 mg (Shafa Company) Memantine tablets as one tablet after a detailed history and confirmation of the patient's obsession.
Category
Treatment - Drugs
2
Description
Control group: In addition to the routine bipolar treatment, placebo tablets, which are similar to memantine tablets in terms of shape, smell, taste, size, and color, and are prepared by the Faculty of Pharmacy of Ahvaz University, are received in the same way as the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry Department of Golestan Hospital
Full name of responsible person
Hamzeh Rostami
Street address
Golestan St., Esfand St., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3311 0000
Email
Rostami_h@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan St., Esfand St., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
zakerkish-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hamzeh Rostami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan St., Esfand St., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3311 0000
Fax
Email
Rostami_h@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamzeh Rostami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan St., Esfand St., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3311 0000
Fax
Email
Rostami_h@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamzeh Rostami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Golestan St., Esfand St., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3311 0000
Fax
Email
Rostami_h@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available