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

Investigating the status of depressive and cognitive and fatigue symptoms in patients with post stroke depression in the modafinil and citalopram group compared to the citalopram and placebo group

Clinical trial with control group, with parallel groups, double-blind, randomized, phase three, on 66 patients with post stroke depression are divided into two groups of 33 people by lottery

Patients visiting the neurology clinic and patients admitted to the stroke department of Rofeideh Rehabilitation Hospital with Post-Stroke Depression randomly divided into two groups and random codes will be assigned to them. One group Modafinil and Escitalopram and the other group will receive placebo and Escitalopram daily for 6 weeks; Medicines with a similar appearance and coded that only the manufacturing company and the analyzing person are aware of the distribution method, none of the plan executive, researcher, patients and drug distributor till the end of the study, will not be informed about the concept of codes. Before the start and every two weeks afte start symptoms are checked with relevant tests.

Inclusion criteria are age above 20 years, the diagnosis of post-stroke depression,which also has symptoms of fatigue and cognitive impairment, reading and writing literacy,and the conditions for not entering are a history of depression, dementia, other psychiatric diseases, the presence of a disease with fatigue as a proven manifestation before stroke, pregnancy or the desire to become pregnant, breastfeeding and the presence of contraindications for taking Escitalopram or Modafinil

66 patients with post-stroke depression will be included in the two groups of intervention group Ecitalopram and modafinil and the control group Ecitalopram and modafinil

Depression; Cognition; Fatigue

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.

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.

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.

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.

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)

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.

University of Rehabilitation and Social Health

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.