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

Evaluation of the efficacy of piracetam in improving cognitive impairment in elderly patients with major depressive disorder.

The study is a double-blind, randomized clinical trial with parallel groups. Participants will be randomized 1:1 into intervention and control groups using Excel's RAND function. The sample size will be 90 eligible patients (45 per group), aged 60-80, from Khorshid Hospital in Isfahan.

The present study is a double-blind, randomized trial conducted on 90 eligible patients. Patients are randomly assigned to two groups: one receiving piracetam (800 mg daily) and the other receiving a placebo. The assessor (principal investigator), patients, and treating physician are blinded to group assignment. Cognitive function is compared using the NUCOG test before and after the 3-month study period.

Inclusion: Age 60-80, MDD per DSM-5, NUCOG <80, stable antidepressants ≥8 weeks. Exclusion: Severe liver/kidney disease, cognitive-affecting drugs/supplements, withdrawal consent, life-threatening events.

Intervention Group: Patients receive standard antidepressants plus an 800 mg piracetam tablet three times daily. Control Group: Patients receive placebo capsules (800 mg Avicel), identical in appearance to the active drug, for three months.

Primary Outcomes: - Mean total NUCOG score before and after the study, within and between the piracetam and placebo groups. Secondary Outcomes: - The trend of NUCOG score changes over time and between groups. - Frequency of adverse events in the piracetam group.

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).

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.

All data can potentially be shared after de-identifying of individuals.

6 months after the publication of the results.

Researchers employed in academic and scientific institutions.

The use of documents with proper citation is permitted.

Email to the corresponding author. Mahsa Panahishokouh mahsapanahishokooh@gmail.com

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.