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IRCT20231106059971N1 IRCT 2024-01-09 University of social welfare and rehabilitation sciences The Effect of Augmenting Modafinil to Escitalopram on Depressive, Cognitive and Fatigue Symptoms in Patients with Post-Stoke Depression The Effect of Augmenting Modafinil to Escitalopram on Depressive, Cognitive and Fatigue Symptoms in Patients with Post-Stoke Depression:A Randomized, Double-blind, Placebo-Controlled Clinical trial 2024-01-10 anticipated 66 Complete https://irct.ir/trial/73901 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling by lottery (names of patients are written on a paper and placed in a box, then the papers are removed one by one until the sample size of the desired group is complete) will be divided into two groups: Placebo plus Escitalopram group: This group will receive placebo and oral Escitalopram (10 mg daily) for 6 weeks. Modafinil plus Escitalopram group: These patients will receive Modafinil (200 mg daily) and oral Escitalopram (10 mg daily) for 6 weeks, Blinding description: In the Double-Blind method the Patient, Researcher, Evaluator and The threated Group are all independent of each other and neither will be informed of the patients groups and their medications. According to random numbers which given to each individual, patients will divided into two groups; The Treated group With Escitalopram and Modafinil (Intervention group) and Placebo and Escitalopram group (Control group) and each Group will assigned a code with which the main drugs and placebo are coded and are provided in the same package to each group and only at the end of the study, when interpreting the data, the codes will be identifiable to the Researcher and Evaluator in order to access the subgroup related to each code (Intervention group or Control group). Until then, Only the Analyst and Drug manufacturer will know how the people in each group are distributed and the concept of the code which assigned to each group. Participants are aware that they are participating in the study and will be given an informed consent form to participate; but will not be aware of the type of medication they took until the end of the study.A person in the ward Nursing staff, who is outside the research team, is used to distribute the medicine; This person also does not know about the assignment of groups and distributes medicines among the candidates based on these codes. Also, due to the use of placebo with the same Color and taste, the type of drug can not be distinguished from the main drug. The only exception to breaking the code is the occurrence of complications that require each subject to know the type of drug, in which case how to do it and the person who can break the code is clear; and this person will not be the main researcher or evaluator, The patient will also be excluded from the study. 3 Post-Stroke Depression. Intervention group: 33 patients diagnosed with Post-Stroke Depression are given 5 mg of Escitalopram, and if there are no side effects, it is increased to 10 mg after two weeks, they are also given 100 mg of modafinil, which is if there are no side effects after two weeks, it is increased to 200 mg and two drugs are continued for 6 weeks. Control group: Another 33 patients diagnosed with Post-Stroke Depression were given 5 mg of Escitalopram, which was increased to 10 mg after two weeks if there were no side effects, and they were also given a placebo, which both medications will be continued for 6 weeks.. Yes - There is a plan to make this available What will be shared: Participants' data file :After unrecognizabling the individuals ,the section on the main outcome and results of the study will be published and other information will be kept by the researcher and will be available to other researchers if needed. Study protocol: How to do the study in detail will be published .Informed consent form :The raw form will be published ,but the form related to each patient can not be published due to the fact that it contains the patient's name and some personal information ,but will remain with the researcher Clinical study report :The result of the study will be published in a transparent manner along with the result of statistical analysis. When: 6 months after the end of the study and the final analysis ,the initial information will be published.The final results will be available at the same time as the results are published. To whom: Access to the dissertation is based on the university mechanism and the rules of the educational center and is available for academic and scientific institutions.If the article is published,the results will be available to the public.(subject to the rules of the relevant journal) Conditions: Access to non-personally identifiable data and other documents is under the supervision of the University Ethics Committee,and at its discretion the authority will have limited access to additional research. Where to obtain: University of Rehabilitation and Social Health How to obtain: Referral to the University of Rehabilitation and Social Health, review of the application by the ethics committee,review of the application by the graduate unit,if approved by the university, as well as obtaining approval and consent from the lead researcher regarding the use of data in another study, documents will be available. Comments:
public Nazila Jabbari Nejad
Unit 172., Kosar Complex., Pas Farhangian Alley., Northern Etaati St., Marzdaran Blvd
Tehran Iran (Islamic Republic of) 1464844756 +98 21 8828 0126 nazilajabbari69@gmail.com University of social welfare and rehabilitation sciences scientific Nazila Jabbari Nejad
Unit 172., Kosar Complex., Pas Farhangian Alley., Northern Etaati St., Marzdaran Blvd
Tehran Iran (Islamic Republic of) 1464844756 +98 21 8828 0126 nazilajabbari69@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Patients'age must be older than 20 years. ischemic stroke or intracerebral hemorrhage at least 21 days after cerebrovascular accident. Modified Rankin Scale (MRS) score must be 3 or less. Consent to participate in the study. Having a diagnosis of post-stroke depression with a HAM-D score above 8. The patients must be literate. MoCA must be above 18. Constant fatigue reported by the patient with an MFI-20 score equal to 12 or more. 20 years no limit Both History of depression, dementia or other psychiatric diseases before stroke Having other diagnoses with fatigue as a known symptom Use of Benzodiazepines or Antiepileptic drugs History of other brain diseases or trauma within 30 days before screening Pregnancy or intention to become pregnant, breastfeeding F06.31 Mood disorder due to known physiological condition with depressive features Treatment - Drugs Intervention group: 33 patients diagnosed with Post-Stroke Depression are given 5 mg of Escitalopram, and if there are no side effects, it is increased to 10 mg after two weeks, they are also given 100 mg of modafinil, which is if there are no side effects after two weeks, it is increased to 200 mg and two drugs are continued for 6 weeks. Control group: Another 33 patients diagnosed with Post-Stroke Depression were given 5 mg of Escitalopram, which was increased to 10 mg after two weeks if there were no side effects, and they were also given a placebo, which both medications will be continued for 6 weeks. Depression score in Hamilton Depression Rating Scale. Timepoint: At the beginning of the study and 2, 4 and 6 weeks after the start of the intervention. Method of measurement: Depression score in Hamilton Depression Rating Scale. Fatigue score in Fatigue Severity Scale. Timepoint: At the beginning of the study and 2, 4 and 6 weeks after the start of the intervention. Method of measurement: Fatigue Severity Scale. Cognitive function score in Montreal Cognitive Assessment. Timepoint: At the beginning of the study and 2, 4 and 6 weeks after the start of the intervention. Method of measurement: Montreal Cognitive Assessment. University of social welfare and rehabilitation sciences Approved 2023-09-27 Ethics committee of the University of Social Welfare and Rehabilitation sciences Kodakyar Ave., Daneshj Blvd., Evin Tehran Tehran Iran (Islamic Republic of)