Comparison of the effects of Naltrexone versus placebo on memory deficit followed by Electroconvulsive therapy in depressed patients: A double blind clinical trial
Electroconvulsive therapy (ECT) is famously known as a treatment for psychiatric disorders as in particular depressive illness. In this regard, memory impairments have always been a focus of concern. Various pharmacological agents have been studied to assess their possible effect in attenuation of memory and other cognitive adverse effects. In this randomized placebo-controlled study 40 depressed patients aged 18 to 65, candidate for six ECT sessions, who met DSM IV criteria for Major Depressive Episode were eligible. The effect of capsule Naltrexone versus placebo which is prescribed the night before ECT sessions , in memory deficit induced by ECT is being assessed. The Whechsler memory questionnaire will be filled out by face to face interview with patients, at the day before ECT sessions, two weeks, one month and three months after ECT sessions. Hamiltone Depression Rating Scale will also be filled out before and 3 months after ECT session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060628309N1
Registration date:2016-09-02, 1395/06/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Somayeh Motazedian
Name of organization / entity
Fasa University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 301 2895
Email address
so.motazedian@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Naltrexone versus placebo on memory deficit followed by Electroconvulsive therapy in depressed patients: A double blind clinical trial
Public title
The effect of Naltrexone on memory deficit induced by Electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : aged 18 to 65 years; major depression or bipolar depression disorder patients based on DSM4 criteria; indicated for ECT
Exclusion criteria: affected by a prominent medical condition; diagnosed with schizophrenia or mania; a history of ECT in the last 6 month; recent opioid use
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
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
Random number Table
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Medical University
Street address
Shahid Beheshti Medical University, Tehran
City
Tehran
Postal code
Approval date
2011-09-24, 1390/07/02
Ethics committee reference number
9169
Health conditions studied
1
Description of health condition studied
Depressive Episode
ICD-10 code
F32
ICD-10 code description
Depressive episode
2
Description of health condition studied
Memory deficit induced by electroconvulsive therapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Memory deficit
Timepoint
At the day before ECT sessions, two weeks, one month and three months after ECT sessions
Method of measurement
Wechsler memory test
Secondary outcomes
1
Description
Depression severity
Timepoint
Before and 3 months after ECT session
Method of measurement
Hamilton Depression Questionair
Intervention groups
1
Description
Intervention Group: Naltrexone cap 50 mg , The night before ECT session
Category
Treatment - Drugs
2
Description
Control Group:
Placebo Capsule
The afternoon before ECT session
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Psychiatry, Imam Hossein Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Zahiroddin
Street address
Imam Hossein Hospital, Shahid Madani St. Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Beheshti 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
Fasa university of medical sciences
Full name of responsible person
Somayeh Motazedian
Position
Psychiatrist
Other areas of specialty/work
Street address
Psychiatric Department. Dr Ali Shariati Hospital, Fasa
City
Fasa
Postal code
Phone
+98 71 5331 4234
Fax
Email
somayehmotazedian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Unoversity of Medical sciences
Full name of responsible person
Alireza Zahiroddin
Position
Professor
Other areas of specialty/work
Street address
Shahid Madani St, Imam Hossein Hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 7755 1023
Fax
Email
alirezazahiroddin@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Somayeh Motazedian
Position
Psychiatrist
Other areas of specialty/work
Street address
Psychiatric Department, Dr Ali Shariati Hospital. Fasa