Protocol summary

Summary
The purpose of this study is investigation of the effectiveness of memantine on cognitive performance in patients treated with ECT. This study is a double-blind placebo- controlled clinical trial. The population of the study is patients that candidate for ECT who are between 18 and 60 years of age and 4 to 12 sessions of ECT that agree with informed consent and do not have dependency or abuse of alcohol or drugs (except nicotine or caffeine) within 3 months prior admission, do not have contraindications for Memantine, seizures, delirium, dementia, do not have cognitive impairment, do not be in lactation or pregnancy phase, and no history of taking Memantine from 3 months prior to admission and drug that have interaction with Memantine. Sample sixe has been (in both intervention and control groups) evaluated 20 cases. Intervention in this study is Memantine or placebo in intervention and control groups 48 hours before ECT until 24 hours after completion of ECT course, which is used with 10 mg two times a day . outcome variables of the study are cognitive status, short-term memory, concentration and precision that will be checked with mini mental state examination scores(MMSE) and digit span test figures (one of the subtests of the Wechsler).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072314122N1
Registration date: 2013-12-28, 1392/10/07
Registration timing: na

Last update:
Update count: 0
Registration date
2013-12-28, 1392/10/07
Registrant information
Name
Azad Maroufi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 0025
Email address
maroufi@muk.ac.ir
Recruitment status
Not enough for processing
Funding source
kurdistan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Memantine on Cognitive Performance of Patients Under Electro Convulsive Therapy
Public title
Efficacy of Memantine on Cognitive Performance of Patients Under Electro Convulsive Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
This study was done on patients in Sanandaj in 1392 in Qods hospital admissions and physician elected to receive ECT. Inclusion criteria: Patients between 60-18 years of age who are candidates for ECT; Patient or legal guardian to sign an informed consent form; Number of ECT sessions is between 4 to 12 sessions; Location is the city of Sanandaj. Exclusion criteria: Abuse or dependence on alcohol and drugs during the 3 months prior to admission (excluding nicotine or caffeine); Proven kidney disease (Renal Failure proven); Epilepsy; Mental Retardation based on clinical evaluation Resident Project; Delirium, Dementia and Cognitive disorders; Pregnancy and lactation; Use of Memantine than 3 months prior to admission; Patients who are receiving Thiazide diuretics; History of allergic symptoms and side effect with Memantine.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
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
Kurditan University of Medical Sciences
Street address
Pasdaran Ave., Quds hospital campus
City
Sanandaj
Postal code
13446-66177
Approval date
2013-09-18, 1392/06/27
Ethics committee reference number
14,21648

Health conditions studied

1

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F20-F21-F2
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders

2

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F30-F31-F3
ICD-10 code description
Mood [affective] disorders

3

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F40-F41-F4
ICD-10 code description
Neurotic, stress-related and somatoform disorders

4

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
Disorders
ICD-10 code description
F60-F61-F62-F63-F64-F65-FF66-F67-F68-F69

5

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
Disorders
ICD-10 code description
F60-F61-F62-F63-F64-F65-FF66-F67-F68-F69

6

Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F99
ICD-10 code description
Unspecified mental disorder

Primary outcomes

1

Description
Cognitive function
Timepoint
ECT prior to and after completion of the
Method of measurement
MMSE and Digit Span Test

Secondary outcomes

1

Description
duration of the sizure
Timepoint
During ECT sessions
Method of measurement
View and review patient records

2

Description
Delayed onset sizure
Timepoint
Electric convulsive therapy during hospital stay
Method of measurement
patients visit and file check

Intervention groups

1

Description
cap memantine first day 5 mg capsule twice a day and the second day, three times a day, then 10 mg capsule twice a day (morning and night) until the end of ECT treatment
Category
Treatment - Drugs

2

Description
Placebo capsules, starch capsules 5 mg in the morning and evening of the first day, second day morning noon and night and then 10 mg capsules morning and night until the end of ECT treatment
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghods hospital in Sanandaj
Full name of responsible person
Dr Azad Maroufi, psychiatrist, professor of Kurdistan University of Medical Sciences
Street address
Shohadaye Niruye Entezami Boulvar,Sanandaj
City
sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Fardin Gharibi، Research Assistant
Street address
Research of 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 Sciences
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
Azad Maroufi
Position
Psychiatrist Kurdistan University of Medical Sciences
Other areas of specialty/work
Street address
Pasdaran street below the Pardis, Ghods hospital, Sanandaj
City
Sanandaj
Postal code
66177_13446
Phone
+98 87 1666 4646
Fax
+98 87 1666 4654
Email
marufi@muk.ac.ir
Web page address
www.muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Azad Maroufi
Position
Psychiatrist
Other areas of specialty/work
Street address
Pasdaran street below the pardis, Ghods hospital, Sanandaj
City
Sanandaj
Postal code
66177_13446
Phone
+98 87 1666 4646
Fax
+98 87 1666 4654
Email
maroufi@muk.ac.ir
Web page address
www.muk.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Azad Maroufi
Position
Psychiatrist Kurdistan University of Medical Sciences
Other areas of specialty/work
Street address
Pasdaran street below the pardis, Ghods hospital, Sanandaj
City
Sanandaj
Postal code
66177_13446
Phone
+98 87 1666 4646
Fax
+98 87 1666 4654
Email
maroufi@muk.ac.ir
Web page address
www.muk.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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