Evaluating the efficacy of adding rivastigmin to a selective serotonin re-uptake inhibitor,Sertraline, in the treatment of major depressive disorder :a pilot study
The aim of this study is to evaluate efficacy and safety of adding rivastigmin to sertraline to improve memory and depressive symptoms in patients with major depression.Twenty outpatients with Major Depressive Disorder based on DSM-V will be included are randomly divided into the intervention and control groups. Subjects in the intervention group receive rivastigmin with an initial dose of 1.5 mg/day from first to third days, which is increased to 3 mg/day on the fourth day and continue with the same dose until the end of the study along with sertraline for three months .The control group receive sertraline with placebo for three months. All depressive patients are managed based on the guidelines of the American Psychiatric Association. The diagnosis is made by two psychiatrists independently, according to the DSM-V criteria. The dose of sertraline will be remained constant during the study period and only co- medication with benzodiazepines is allowed. Wechsler Memory Scale, designed to measure intelligence in adults and older adolescents, and the Hamilton Depression Rating Scale, "Gold Standard" for rating depression in clinical research, are assessed at the baseline and on the third month. Side effects will be assessed with direct questions and observing main complications weekly.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020132236N4
Registration date:2017-03-05, 1395/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-05, 1395/12/15
Registrant information
Name
Narjes Hendouei
Name of organization / entity
Department of Pharmacotherapy, Faculty of Pharmacy and Psychiatry and Behavioral Sciences Research C
Country
Iran (Islamic Republic of)
Phone
+98 911 327 0107
Email address
nhendoei@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of adding rivastigmin to a selective serotonin re-uptake inhibitor,Sertraline, in the treatment of major depressive disorder :a pilot study
Public title
Efficacy of rivastigmin in the treatment of major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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 Imam khomeini hospital clinic.
Exclusions criteria:
Psychiatric comorbidity(primary or secondary diagnosis of bipolar I disorder, either manic or mixed episode, as defined by DSM-V);History of substance dependence (including alcohol, but excluding nicotine) as defined by DSM-V and relapse within the past 6 months, or substance abuse within the 3 months preceding the trial or positive urine test for illicit drugs;Electroconvulsive therapy during the 6 past months;Suicidality(active suicide or homicide intent, or a suicide or homicide attempt in the preceding 6 months);Mental retardation;Pregnant or at risk of pregnancy; Cognitive disorders such as dementia, delirium, or amnesia, traumatic brain injury;Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values;Hypersensitivity to rivastigmin;Previous treatment with rivastigmin in the past year; History of neuroleptic malignant syndrome;Patients under treatment cholinesterase inhibitors, N-methyl D-aspartate (NMDA) receptor antagonists;Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
Age
From 25 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ethical committee of Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
Street address
Vice chancellor for research, Moallem Square, Mazandaran University of Medical Sciences
City
Sari
Postal code
Approval date
2014-09-07, 1393/06/16
Ethics committee reference number
16/6/1393
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode
Primary outcomes
1
Description
Memory
Timepoint
At the baseline and on the third month
Method of measurement
Wechsler Memory Scale
Secondary outcomes
1
Description
Depression severity assessment
Timepoint
At the baseline and on the third month
Method of measurement
Hamilton Depression Rating Scale
2
Description
Rivastigmin side effects
Timepoint
Weekly
Method of measurement
With direct questions and observing main complications
Intervention groups
1
Description
The control group receive sertraline with placebo for three months.
Category
Placebo
2
Description
Subjects in the intervention group receive rivastigmin with an initial dose of 1.5 mg/day from first to third days, which is increased to 3 mg/day on the fourth day and continue with the same dose until the end of the study along with sertraline for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital-Psychiatry clinic
Full name of responsible person
Narjes Hendouei
Street address
Imam Khomeini hospital, Razi street
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
Street address
Vice chancellor for research, Moallem Square, Mazandaran University of Medical Sciences
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
Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Narjes Hendouei
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Pharmacotherapy, Faculty of Pharmacy,Mazandaran University of Medical Sciences, 17 Km Sea road
City
Sari
Postal code
Phone
+98 11 3354 3081
Fax
Email
hendoieen@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Narjes Hendouei
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Pharmacotherapy, Faculty of Pharmacy,Mazandaran University of Medical Sciences, 17 Km Sea road
City
Sari
Postal code
Phone
+98 11 3354 3081
Fax
Email
hendoieen@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Pharmacotherapy, Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Narjes Hendouei
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Pharmacotherapy, Faculty of Pharmacy,Mazandaran University of Medical Sciences, 17 Km Sea road
City
Sari
Postal code
Phone
+98 11 3354 3081
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)