This study is a randomized double blind clinical trial which is being done in Sari at 2014-2015. The study is to determine the effects of adding Donepezil to Sertraline in the treatment of Major Depressive Disorder and it is scheduled to assess the effects of this addition on memory and depression. Forty outpatients with Major Depressive Disorder based on DSM-IV-TR will be included if they have no history of serious medical or psychiatric disorders other than depression. Patients will be randomly allocated to Donepezil (5 mg) or placebo added to Sertraline. At baseline, Wechsler Memory Scale and the Hamilton Depression Rating Scale will be done. During 3 months of treatment symptoms will be checked by Hamilton Depression Rating Scale every four weeks and Wechsler memory scale at the end of study and three months later. Side effects will be assessed with direct questions and observing main complications
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031011885N2
Registration date:2014-12-01, 1393/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-01, 1393/09/10
Registrant information
Name
Samaneh Farnia
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 5659
Email address
sfarnia@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2014-07-10, 1393/04/19
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of adding Donepezil to a selective serotonin re-uptake inhibitor (Sertraline) in the treatment of major depressive disorder
Public title
Efficacy of Donepezil in the treatment of Major Depressive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Entry: All outpatients with Major Depressive Disorder based on DSM-IV-TR in the age range of 25-55 year old who refer to psychiatric clinic in Zare hospital or Tooba clinic. Exclusion criteria: Catatonia; Acute suicidal idea; Major past medical history; Endocrine diseases; Chronic cardiovascular diseases; Respiratory diseases; Hepatic failure; Renal failure; Active peptic ulcer, Acute infectious diseases; Malignancies; Neurolgic disorders; Axis I psychiatric disorders except of Major depressive disorder; Axis II psychiatric disorders; Family history of bipolar disorder; Concomitant use of psychiatric drugs except for Antidepressants; Outside the age range of 25-55; refuse to participate in the study; Pregnancy, Breastfeeding; Lack of contraception in women of childbearing age.
Age
From 25 years old to 55 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
This is a randomized double-blind controlled study. The participants and assessor are aware of neither drugs nor placebo. The block randomization method is used .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciencesnces
Street address
moallem square
City
sari
Postal code
Approval date
2014-07-09, 1393/04/18
Ethics committee reference number
93/4/18
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
f32.2
ICD-10 code description
Sever Depressive Episode Without Psychotic Symptoms
Primary outcomes
1
Description
Memory
Timepoint
Before intervention,End of intervention,3months after ending intervention
Method of measurement
With wechsler memory scale
2
Description
Depression
Timepoint
Before intervention,Every month for three months after beginning intervention,3months after ending intervention
Method of measurement
With hamilton depression rating scale
Secondary outcomes
1
Description
Side effects of drugs
Timepoint
1st,2st.3st month after intervention and three month after ending intervention
Method of measurement
By filling a checklist of drug side effects
Intervention groups
1
Description
Intervention group: Twenty patients receive donepezil tablet 5 miligram/daily plus sertraline tablet 50 -100 miligram/day given orally up to three months.
Category
Treatment - Drugs
2
Description
Control group: Twety patients receive placebo .It is made similar to donepezil tablet by pharmaceutical industry experts.The placebo is added to sertraline. It is given orally up to three months .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zare hospital-Psychiatry clinic
Full name of responsible person
Dr.Samaneh farnia
Street address
Zare hospital-Neka road
City
Sari
2
Recruitment center
Name of recruitment center
Tooba center psychiatry clinic
Full name of responsible person
Dr.Samaneh farnia
Street address
Khazar square,Tooba center
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Moallem street-Moallem square-Vice chancellor for research
City
Sari
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, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Seid Davood Hosseini Talari
Position
Psychiatrist Assistant
Other areas of specialty/work
Street address
Zare Hospital, Neka Road
City
Sari
Postal code
Phone
+98 11 3311 7746
Fax
Email
hosseni1497@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Samaneh farnia
Position
Assistant professor
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Sari
Postal code
Phone
+98 11 3336 1701
Fax
Email
sfarnia@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)