Comparison of gene expression and Brain-derived neurotrophic factor in patients with major depressive disorder treated with fluoxetine and cognitive-behavioral therapy.
Design
The type of study is a randomized clinical trial on the one hand
R software will be used for randomization.
Sample size: 40 people
Patients will be treated in one of two groups: medication and behavior.
Settings and conduct
The research community consists of patients with major depressive disorder who refer to Zare Psychiatric Hospital and the private ward of Sari. Blood samples are taken from patients before and after the intervention and examined for BDNF protein and gene expression.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1-Diagnosis of major depressive disorder
2-pass school grade above 9
3Having at least physical and cognitive ability
4-Lack of psychosis is a serious thought that hurts yourself and others.
5.Failure to receive other psychological treatment at the same time
exclusion criteria:
1-Acute psychiatric disorders according to the psychiatrist.
2-The occurrence of serious and restrictive medical diseases.
3.Age range between 18-55 years.
4.Taking other psychotherapeutic drugs.
Intervention groups
Intervention group: Patients with major depressive disorder who are treated with cognitive-behavioral therapy for 12 sessions. In this treatment model, patients with major depression are treated based on their mentality and behavior and various problems ranging from anxiety and depression to a variety of personality disorders.
Control group: Fluoxetine treatment group that receives 20 mg of the drug daily for 3 months.Medication therapy is an accepted method by which cognitive-behavioral therapy is compared.
Main outcome variables
Clinical examination of patients
Age of onset of the disease
The duration of the disease
gene expression
BDNF protein
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190710044171N1
Registration date:2020-09-08, 1399/06/18
Registration timing:registered_while_recruiting
Last update:2020-09-08, 1399/06/18
Update count:0
Registration date
2020-09-08, 1399/06/18
Registrant information
Name
Hossein Ghalehnoei
Name of organization / entity
Mazandaran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 9337
Email address
hossein.ghalehnoei58@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of gene expression pattern in blood sample of depressed patients treated with fluoxetine and cognitive-behavioral therapy
Public title
comparison gene expression pattern in blood sample of patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of major depression
Range 18-55 years
Graduated from middle school
Having minimum physical and cognitive abilities to participate in intervention sessions
Lack of psychosis and hurting oneself and others
Not receiving any other psychological treatment at the same time
Exclusion criteria:
Acute psychiatric disorders according to the psychiatrist
Having a serious medical condition and limiting
Taking intervening drugs
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
One sample is taken before the intervention and one sample is taken after the intervention.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with MDD disorder are identified by a physician based on the DSM-V criteria. The degree of depression of patients is determined by self-assessment based on the Beck questionnaire. Patients are randomly divided into two groups according to Graphpad online software: CBT (intervention) therapies are divided.
Blinding (investigator's opinion)
Single blinded
Blinding description
Cognitive-behavioral group therapy is the study of the blind study group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthic committee Mazandaran of medical sciences
Street address
Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences-Moallem Square-Moallem Street-Sari-Iran.
City
sari
Province
Mazandaran
Postal code
4817844718
Approval date
2019-08-07, 1398/05/16
Ethics committee reference number
IR.MAZUMS.REC.1398.759
Health conditions studied
1
Description of health condition studied
major depressive disorder
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
change of gene in trial
Timepoint
evaluation of change in gene after 6 weeks treatment
Method of measurement
gene description
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group receiving 12 sessions of cognitive-behavioral therapy is a group that psychotherapists use to educate people and change their feelings and behaviors through their thought patterns and beliefs. Each session lasts 90 minutes. Control group: Drug therapy group in which patients take 20 mg of fluoxetine daily for 3 months.
Category
Other
2
Description
Control group: Control group: In the drug therapy group, patients receive 20 mg of fluoxetine daily for three months.