The Effect of Augmenting Modafinil to Escitalopram on Depressive, Cognitive and Fatigue Symptoms in Patients with Post-Stoke Depressio

Phase 3

Recruiting

• Conditions: Post-Stroke Depression.; Mood disorder due to known physiological condition with depressive features; F06.31

• Registration Number: IRCT20231106059971N1
• Lead Sponsor: niversity of social welfare and rehabilitation sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.