Comparison of The Effect of Modafinil and Citalopram On The Treatment of Major Depression
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 30 patients. Block randomization
Settings and conduct
Therapeutic intervention on clients of the psychiatric clinic of Golestan Hospital in Ahvaz in a three-way blind (project facilitator, patient and project consultant) by similar and pre-determined drug packages by the study supervisor
Participants/Inclusion and exclusion criteria
Entering criteria:
1. Age between 18-65 years. 2. Initial clinical diagnosis of major depressive disorder. 3.Written consent to enter the study from the patient or his / her guardian. 4.Ability to take medicine. 5. Hamilton Depression Score above 25.
Exclusion criteria:
1. Depression caused by a physical illness or the use of drugs and substances
2. Existence of any severe and chronic physical illness 3. History of gastric ulcer 4. Pregnancy 5. History of alcohol and substance abuse during the 6 months before the start of the project 6. History of manic episodes 7.Intellectual disorders 8. Psychosis 9. Breastfeeding 10. High severity of depression 11. History of receiving antidepressant in two to four weeks before starting the drug 12.History of no Responding or having shifts with the studied drugs 13. History of receiving lithium, lamotrigine, sodium valproate, atypical antipsychotics available other than ziprasidone and aripiprazole, in the past two weeks or one month 14. Being treated with Ritalin 15. Existence of mixed symptoms in the recent episode 16. Existence of anxiety disorder
Intervention groups
The intervention group receives modafinil 200 mg every morning and evaluates in 3rd and 6th week after start.
The control group receives citalopram 40 mg daily and evaluates in 3rd and 6th week after start.
Main outcome variables
The treatment of major depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201026049152N1
Registration date:2020-11-28, 1399/09/08
Registration timing:registered_while_recruiting
Last update:2020-11-28, 1399/09/08
Update count:0
Registration date
2020-11-28, 1399/09/08
Registrant information
Name
Golsa Safaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 6894
Email address
golsa.safaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Effect of Modafinil and Citalopram On The Treatment of Major Depression
Public title
Comparison of The Effect of Modafinil and Citalopram On The Treatment of Major Depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 65 years
Diagnosis of clinical Major Depressive Disorder based on the DSM5 criteria
A score above 25 on the Hamilton Depression Rating Scale
Written consent to enter the study from the patient or her /his guardian
The patient is able to take medicine
Exclusion criteria:
Depression caused by physical illness or the use of drugs and substances
Existence of any severe and chronic physical illness (brain, cardiovascular disease, seizure or history of substance abuse)
History of gastric ulcer
Pregnancy
History of alcohol use and substance abuse during the 6 months prior to the start of the project
History of manic episodes
Intellectual disorders
Psychosis
Breastfeeding
High severity of depression such as melancholic and suicidal ideation
History of receiving antidepressant in two to four weeks before starting the drug (eg MAOIs in the last four weeks but SSRIs or mirtazapine or SNRIs in the last two weeks)
History of non-response or shifting with the studied drugs
History of receiving lithium, lamotrigine, sodium valproate, atypical antipsychotics available other than ziprasidone and aripiprazole, in the past two weeks or one month (depending on the half-life of the drug or based on similar studies)
Being treated with Ritalin for any reason
Existence of mixed symptoms in the recent episode
Existence of anxiety disorder, especially panic
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used.
The main idea of block randomization is to divide patients into M blocks of size 2N, so that in each block N patients are assigned A and patients N are assigned to B. The block is then randomly selected. This method ensures equal treatment allocation per block provided the block is fully utilized.
The size of the block, depending on the number of treatments, should be short enough to prevent imbalance, and large enough to prevent guessing treatment allocation in each group during the study. The block size should be at least twice the number of treatment nodes. The size of the block is not stated in the study so that researchers are blind to it.
If the blocks are expressed, the treatment series in each block can be guessed. This can lead to selection bias.
The solution to prevent this error is to:
(1) Lack of disclosure of block mechanism (2) Use of random block size
In both groups, the drugs will be given to the patients in the same way and they will receive the medicine on the same days and in the same way. Everyone on the research team, like patients and their families, will be unaware of the treatment groups designed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients are treated with medication packages pre-determined by the study supervisor (supervisor Professor)
Drug packages are completely similar in shape and the patient and the project manager are not aware of the contents of the packages. In addition, collecting information, assessing patients and completing the forms is done by the project manager and his assistant who are not aware of the contents of the packages. ; In the data analysis stage, the analysis will be performed by the project consultant and the project manager who are not aware of the contents of the drug packages and only the group of patients (group 1 or 2) will be identified for data analysis; Therefore, the study is three way blind and the contents of the two drug groups are not clear from the stage of the patient entering the study to conduct the study, data collection and analysis of information.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jondishapur University of Medical Sciences
At the beginning of the study and three weeks and six weeks after the start of the intervention
Method of measurement
The Hamilton questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group receives 200 mg of modafinil (2 of 100 mg tablets made in Iran) every morning and will be re-evaluated by Hamilton Depression Inventory three weeks and six weeks after the start of the intervention.
Category
Treatment - Drugs
2
Description
Control group: This group receives two 20 mg citalopram tablets made in Iran, which have been standardized with modafinil, equivalent to 40 mg citalopram every day, and will be re-evaluated by Hamilton questionnaire three weeks and six weeks after the start of the intervention.