The purpose is to study the efficacy of Memantin in the treatment of adult attention-deficit hyperactivity disorder (ADHD). Forty subjects between 18-45 years who clearly meet diagnostic criteria for adult ADHD, from parents and siblings of children with ADHD who are referred to child and adolescent psychiatric clinic of Sanandaj Behsat hospital will assign. Inclusion criteria: confirm of symptoms of ADHD in childhood & diagnosis of ADHD on clinical psychiatric interview. Exclusion criteria: any other psychiatric disorder and physical illness. This is a double blind randomized clinical trial study. Participants will be randomly allocated to receive Memantin (10 mg/day and will be titrated up to 20 mg/day after a week) and placebo for 6 weeks. Patients will assess at baseline, 3 and 6 weeks after the medication start with Adult Conner's questionnaires for assessing severity of symptoms of ADHD. Side effects will systematically record throughout the study and will assess using a checklist that comprises side effects by psychiatrist on weeks 1, 3 and 6.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053028182N1
Registration date:2017-01-10, 1395/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-10, 1395/10/21
Registrant information
Name
Soleiman Mohammadzadeh
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 2168
Email address
dr.mohammadzadeh86@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of memantin in the treatment of adult with attention deficit hyperactivity disorder
Public title
Use of memantin in treatment of adult with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: receiving DSM-IV-TR diagnostic criteria for ADHD; the age range of 18 to 45 years old; not using any psychiatric drugs at least 2 weeks before the research. Exclusion criteria: having mental retardation; having any psychiatric disorders except Oppositional Defiant disorder; allergic history to Memantine; having serious disorder like heart disease; uncontrolled Seizure disorder; individuals with Systolic blood pressure above 125 mmHg or resting pulse under 60 or having above 115 beats per minute: Pregnant and lactating women
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Kurdistan University of Medical Sciences
Street address
Pasdaran Street, Kurdistan University of Medical Sciences
Baseline, third and sixth weeks after intervention
Method of measurement
Conners' Adult ADHD Rating Scales–Self-Report
2
Description
Improvement in Impulsivity symptoms
Timepoint
Baseline, third and sixth weeks after intervention
Method of measurement
Conners' Adult ADHD Rating Scales–Self-Report
3
Description
Improvement in Attention-deficit symptoms
Timepoint
Baseline, third and sixth weeks after intervention
Method of measurement
Conners' Adult ADHD Rating Scales–Self-Report
Secondary outcomes
1
Description
drug side effects
Timepoint
third and sixth weeks after intervention
Method of measurement
checklist of side effects
2
Description
Efficacy in more than 50% of reduction in ADHD diagnostic rating scale
Timepoint
six weeks after treatment
Method of measurement
Parent interview
Intervention groups
1
Description
Therapeutic dosage of Memantine 10 mg is prescribed a tablet daily for the first week (one tablet in the night at 10;00 o'clock, and 2 tablets are daily prescribed in the second week (one tablet in the morning at 8;00 o'clock, one tablet at 10;00 o'clock).
Category
Treatment - Drugs
2
Description
Placebo is prescribed a tablet daily for the first week (one tablet in the night at 10;00 o'clock, and 2 tablets are daily prescribed in the second week (one tablet in the morning at 8;00 o'clock, one tablet at 10;00 o'clock).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Behsat clinic, Behsat Hospital, Kurdistan University of Medical Sciences
Full name of responsible person
Soleiman Mohammadzadeh
Street address
Behsat Hospital, Vakil Street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical science
Full name of responsible person
Farzin Rezaei
Street address
Pasdaran Street, Kurdistan University of Medical Sciences
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan University of Medical science
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
Kurdistan University of Medical Sciences
Full name of responsible person
Soleiman Mohammadzadeh
Position
Child and Adolescent Psychiatry
Other areas of specialty/work
Street address
Behsat Hospital, Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Phone
+98 87 3328 5914
Fax
Email
dr.mohammadzadeh86@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Soleiman Mohammadzadeh
Position
Child and Adolescent Psychiatry
Other areas of specialty/work
Street address
Behsat Hospital, Vakil Street
City
Sanandaj
Postal code
Phone
+98 87 3328 5914
Fax
Email
dr.mohammadzadeh86@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University Of Medical Science
Full name of responsible person
Soleiman Mohammadzadeh
Position
Child and Adolescent Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Behsat Hospital, Vakil Street
City
Sanandaj
Postal code
Phone
+98 87 3328 5914
Fax
Email
dr.mohammadzadeh86@gmai.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)