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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231106059971N1
Enrollment
66
Registered
2024-01-09
Start date
2024-01-10
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Stroke Depression. Mood disorder due to known physiological condition with depressive features

Interventions

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 10

Sponsors

University of social welfare and rehabilitation sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNazila Jabbari Nejad

University of social welfare and rehabilitation sciences

nazilajabbari69@gmail.com+98 21 8828 0126

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026