Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000619640
Ethics application status
Approved
Date submitted
26/05/2014
Date registered
11/06/2014
Date last updated
11/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Memantine on cognition disorders induced by Electroconvulsive therapy (ECT)
Scientific title
A double blind randomized clinical trial to evaluate the effect of oral memantine on the prevention of post ECT cognition disorders
Secondary ID [1] 284665 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post ECT cognition disorders 291993 0
Condition category
Condition code
Mental Health 292338 292338 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of oral memantine 5 mg daily that will be start the day before doing ECT. Adherence monitoring will be done by counting tablet return by patients.Meantime 5mg daily continue throughout the fourth course of ECT (last dose at fourth course of ECT)
Intervention code [1] 289444 0
Treatment: Drugs
Comparator / control treatment
Administartion of placebo tablet like memantine daily with component of microcellolose
Control group
Placebo

Outcomes
Primary outcome [1] 292201 0
Using an objective measure of cognitive function: Modified Mental Status Examination (MMSE).
Timepoint [1] 292201 0
After doing fourth course of ECT in patients
Secondary outcome [1] 308403 0
nil
Timepoint [1] 308403 0
nil

Eligibility
Key inclusion criteria
All patients between 18-60 years old undergoing ECT in the psychosomatic ward of Taleghani hospital(Tehran, Iran) with informed consent
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with renal failure or hepatic failure, those with cardiac block, patients using medications with anticholinergic or NMDA(N-methyl D aspartate) antagonistic effect,pregnant and brearstfeeding women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/02/2014
Actual
28/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 6071 0
Iran, Islamic Republic Of
State/province [1] 6071 0
Tehran

Funding & Sponsors
Funding source category [1] 289293 0
University
Name [1] 289293 0
Shahid Beheshti University of Medical Sciences
Country [1] 289293 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Mohammad Abbasinazari
Address
Department of clinical pharmacy, school of pharmacy,Shahid Beheshti University of Medical Sciences, valiasr street, nyayesh jnction, Tehran, Iran, 1991953381
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 287963 0
Other Collaborative groups
Name [1] 287963 0
Deputy of research of Shahid Beheshti university of medical sciences
Address [1] 287963 0
Deputy of research, School of pharmacy, valiasr street, nyayesh jnction, Tehran, Iran, 1991953381
Country [1] 287963 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291057 0
Shahid Beheshti University of Medical Sciences ethical committee
Ethics committee address [1] 291057 0
eyhical comittee center, school of pharmacy, valiasr street, nyayesh jnction, Tehran, Iran, 1991953381
Ethics committee country [1] 291057 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 291057 0
06/11/2013
Approval date [1] 291057 0
12/12/2013
Ethics approval number [1] 291057 0

Summary
Brief summary
one major complication of electroconvulsive therapy (ECT) is the potential for temporary mild to moderate cognitive impairment. Memantine (a NMDA antagonist agent) has a beneficial effect on cognition in patients with moderate to severe Alzheimer ’s disease. The purpose of this study was to assess the effectiveness of Memantine 5mg/d in the prevention of cognitive impairments during ECT treatment.
A prospective, double blind, placebo controlled trial included 40 patients underwent ECT will be done. Patients will randomly select to receive either memantine 5 mg/d or a placebo. Drug or placebo started the day before doing ECT and continue throughout the fourth course of ECT. An objective measure of cognitive function is Modified Mental Status Examination (MMSE) and will be performed pre-ECT and post-ECT. Finally score of MMSE before and after ECT will be compare.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43118 0
A/Prof Mohammad Abbasinazari
Address 43118 0
Department of clinical pharmacy,School of pharmacy, Shahid Beheshti University of Medical Sciences,Valiasr street, nyayesh junction, Tehran, Iran 1991953381
Country 43118 0
Iran, Islamic Republic Of
Phone 43118 0
+982188873704
Fax 43118 0
Email 43118 0
[email protected]
Contact person for public queries
Name 43119 0
Mohammad Abbasinazari
Address 43119 0
Department of clinical pharmacy,School of pharmacy,Shahid Beheshti University of Medical Sciences, Valiasr street, nyayesh junction, Tehran, Iran 1991953381
Country 43119 0
Iran, Islamic Republic Of
Phone 43119 0
+982188873704
Fax 43119 0
Email 43119 0
[email protected]
Contact person for scientific queries
Name 43120 0
Mohammad Abbasinazari
Address 43120 0
Department of clinical pharmacy,School of pharmacy, Shahid Beheshti University of Medical Sciences,Valiasr street, nyayesh junction, Tehran, Iran 1991953381
Country 43120 0
Iran, Islamic Republic Of
Phone 43120 0
+982188873704
Fax 43120 0
Email 43120 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMemantine in the prevention or alleviation of electroconvulsive therapy induces cognitive disorders: A placebo controlled trial.2015https://dx.doi.org/10.1016/j.ajp.2015.04.002
N.B. These documents automatically identified may not have been verified by the study sponsor.