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IRCT20250929067414N3 IRCT 2026-02-11 Esfahan University of Medical Sciences piracetam consumption in improving cognitive disorders Evaluation of the effectiveness of piracetam consumption in improving cognitive disorders in older adults with major depression disorder: A double-blind, placebo-controlled clinical trial 2026-02-03 anticipated 90 Recruiting https://irct.ir/trial/88858 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process is carried out as follows: After confirming the eligibility criteria and obtaining informed consent, patients are allocated to the intervention and control groups using block randomization with a block size of 4 and with the help of the online software www.sealedenvelope.com. This process is performed by an independent colleague not part of the research team, and the results are placed in sequentially numbered, opaque, sealed envelopes. The principal investigator and the patients will be blinded to the allocation type (double-blind study), Blinding description: To implement double-blinding, the Piracetam and placebo capsules will be identical in appearance and indistinguishable. These capsules will be packaged in opaque, coded boxes (labeled as Code A and Code B). This ensures that neither the participants nor the outcome assessment personnel will be aware of the actual content of the capsules (intervention or control). This process prevents potential bias in participant reports and clinical evaluations. 3 Cognitive impairments associated with major depression in the elderly. Intervention 1: Intervention group: Patients receive an 800 mg oral piracetam tablet (manufactured by Alborz Darou Company) three times daily for 3 months. Intervention 2: Control group: Patients receive a placebo capsule containing 800 mg of Avicel, which is completely similar in appearance to the piracetam tablet, three times daily for 3 months. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identifying of individuals. When: 6 months after the publication of the results. To whom: Researchers employed in academic and scientific institutions. Conditions: The use of documents with proper citation is permitted. Where to obtain: Email to the corresponding author. Mahsa Panahishokouh mahsapanahishokooh@gmail.com How to obtain: Requests for data access must be submitted in writing to the principal investigator, specifying the intended purpose. If approved, coded data (without identifying information) will be provided after signing a confidentiality agreement. Comments:
public Mahsa panahishokouh
hezarjreeb street
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 3792 7040 mahsapanahishokooh@gmail.com Esfahan University of Medical Sciences scientific Mahsa panahishokouh
hezarjreeb street
Isfahan Iran (Islamic Republic of) 73461-81746 +98 912 073 9908 mahsapanahishokooh@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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. 60 years 80 years Both 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. F32.2 Major depressive disorder, single episode, severe without psychotic features Treatment - Drugs Placebo Intervention group: Patients receive an 800 mg oral piracetam tablet (manufactured by Alborz Darou Company) three times daily for 3 months. Control group: Patients receive a placebo capsule containing 800 mg of Avicel, which is completely similar in appearance to the piracetam tablet, three times daily for 3 months 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. 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. Esfahan University of Medical Sciences Approved 2026-01-28 کمیته اخلاق دانشکده داروسازی و تغذیه hezarjreeb street اصفهان Isfehan Iran (Islamic Republic of)