Protocol summary

Study aim
Determining and comparing the total score of the self-report scale of attention deficit hyperactivity disorder (ASRS) in adolescents in the two study groups, before and after the intervention
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 44 patients. Endnote software was used for randomization.
Settings and conduct
The study is a triple-blind randomized clinical trial. Patients, therapists, and statistical consultants are unaware of the control and intervention groups. The target population of the study is adolescents aged 12 to 18 years, and patients in both the intervention and control groups are being treated with long-acting methylphenidate (stimulant) within the therapeutic dose range.
Participants/Inclusion and exclusion criteria
Diagnosis of ADHD by a psychiatrist using a questionnaire Existence of functional deficits in the adolescent Age 12 to 18 years Normal intelligence quotient using an IQ test Exclusion criteria: Presence of major medical disorders (heart disease, diabetes, asthma, renal failure, etc.) Presence of comorbid psychiatric disorders that require pharmacological interventions. Use of another medication in addition to a long-acting stimulant
Intervention groups
In the intervention group receive the drug memantine + long-acting stimulant. The control group receives placebo + long-acting stimulant.
Main outcome variables
The severity of executive dysfunction; the severity of attention deficit and hyperactivity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250917067279N1
Registration date: 2026-01-20, 1404/10/30
Registration timing: registered_while_recruiting

Last update: 2026-01-20, 1404/10/30
Update count: 0
Registration date
2026-01-20, 1404/10/30
Registrant information
Name
Farnaz Golmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
fgmohammadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-10-23, 1405/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding memantine to a long-acting stimulant on executive function deficits in adolescents with attention deficit hyperactivity disorder
Public title
Studying the effect of adding memantine to a long-acting stimulant on executive function deficits in adolescents with attention deficit hyperactivity disorder referred to a pediatric psychiatric clinic in 2015.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of ADHD by a psychiatrist using a questionnaire Presence of functional deficits in the adolescent Age 12 to 18 years Normal intelligence quotient using an IQ test
Exclusion criteria:
Having any medical illness Using any medication except long-acting stimulant
Age
From 12 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who have a history of visiting the clinic and have been treated with a long-acting stimulant, if they are eligible, are included in the study as patients. This method is called sequential sampling. After identifying the study subjects, the first two people show us a block. Then, we randomly assign the subjects in each block to the usual treatment + memantine group (A) and the usual treatment + placebo group (B). The next two people are also randomly assigned to group A and the other to group B until we reach a sufficient sample size.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The therapist only gives the patient the medicine they need for a month based on whether the patient belongs to group A or B, but he is not aware of the contents of the medicine packets A or B, and finally, the statistical consultant is not informed of the patient group when performing statistical calculations.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
isfahan University of Medical Sciences, Hezar Jarib Ave. Azadi Sq.
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2025-09-14, 1404/06/23
Ethics committee reference number
IR.MUI.MED.REC.1404.228

Health conditions studied

1

Description of health condition studied
Attention deficit-hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Executive functioning score in the Brief questionnaire
Timepoint
Upon arrival and 30 days later
Method of measurement
BRIEF questionair

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: patients in this group are given memantine (Alzixa) orally, adding to long-acting stimulant, at a dose of 9 mg daily (divided in three doses daily)
Category
Treatment - Drugs

2

Description
Control group: patients in this group are given placebo at dose of 9 mg daily divided(adding to long-acting stimulants.)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Farnaz Golmohammadi
Street address
Sonbolestan Street.,Ebnesina St.,Isfahan city
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 5051
Email
amin@mui.ac.ir
Web page address
http://amin.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Asgari,Vice President for Research and Technology
Street address
Hezarjarib Ave.,Isfahan,Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Web page address
https://mui.ac.ir/fa
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
Farnaz Golmohammadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Khorshid hospital, Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
81458-33117
Phone
+98 31 3222 2127
Email
fgmohammadi@med.mui.ac.ir
Web page address
https://nour.mui.ac.ir/fa

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnaz Golmohammadi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Khorshid hospital, Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
81458-33117
Phone
+98 31 3222 2127
Email
fgmohammadi@med.mui.ac.ir
Web page address
https://nour.mui.ac.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farnaz Golmohammadi
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Khorshid hospital, Ostandari Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0983136680048
Email
fgmohammadi@med.mui.ac.ir
Web page address
https://nour.mui.ac.ir/fa

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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