Cognitive impairments associated with major depression in the elderly. Major depressive disorder, single episode, severe without psychotic features
Conditions
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: Elderly people aged 60 – 80 years Diagnosis of Major Depressive Disorder (MDD) Based on DSM-5 Criteria Confirmed cognitive impairment with a baseline NUCOG score below 80. Stable antidepressant regimen for at least eight weeks prior to study entry.
Exclusion criteria
Exclusion criteria: Occurrence of severe hepatic or renal disorders. Use of any medication or herbal supplement affecting cognitive function during the study. Unwillingness to continue the trial, at any time and for any reason during the study. Occurrence of specific, life-threatening adverse events such as unexplained bruising, gum bleeding, or sudden headache.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the mean total NUCOG score in patients with Major Depressive Disorder, both within each group and between the piracetam and placebo groups. Timepoint: Before the intervention and at the end of the third month after the start of the intervention. Method of measurement: The Neuropsychiatry Unit Cognitive Assessment (NUCOG) test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of changes in mean scores across different cognitive domains of the NUCOG test over time within each group. Timepoint: Before the intervention and at the end of the third month after the start of the intervention. Method of measurement: NUCOG test.;Determination and comparison of the frequency distribution of adverse effects in the piracetam-receiving and placebo groups. Timepoint: During the intervention with at least monthly monitoring. Method of measurement: Patient interview. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahsa panahishokouh
Esfahan University of Medical Sciences
Outcome results
None listed