]>
IRCT20091019002611N4 IRCT 2019-10-02 Mashhad University of Medical Sciences The efficacy of Modafinil on working memory in patients with major depressive disorder Investigation of the efficacy of Modafinil augmentation of antidepressant treatment on working memory in patients with major depressive disorder: A randomized double-blind clinical trial 2019-10-22 anticipated 90 Complete https://irct.ir/trial/41796 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized block design, table of random numbers, sealed envelopes, Blinding description: Participants are unaware of the target group (intervention or control), researchers and evaluators are unaware of each participant dedicated group. N/A Major depressive disorder. Intervention 1: The intervention group receive Modafinil for eight weeks in addition to standard antidepressant medication with SSRIs or SNRIs. The drug is initially administered for one week at dose of 100 mg/day and then continued at dose of 200 mg/day. Intervention 2: Control group: the intervention group receive placebo for eight weeks in addition to standard antidepressant medication with SSRIs or SNRIs. Yes - There is a plan to make this available What will be shared: Main outcome information; When: Six month after publishing the results; To whom: Researchers working in academic and scientific institutions; Conditions: Requesting the opinion of the project manager before performing any analysis; Where to obtain: ِDr.Mohammad Reza Fayyazi Bordbar fayyazimr@mums.ac.ir How to obtain: Submit request via email, receiving response from project manager; Comments:
public Mohammad Reza Fayyazi Bordbar
]bn-e-Sina hospital, Hor-e-Ameli Blvd., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2701 fayyazimr@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Reza Fayyazi Bordbar
Ebn'e Sina hospital, Horr Ameli Blvd, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3711 2701 fayyazimr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Confirmed history of major depressive disorder based on the DSM-5 criteria, now in the recovery phase and receiving SSRIs or SNRIs Beck Depression Inventory score less than 28 18 to 40 years old The patient has not had more than three episodes Mean score of 30 for positive affect and 15 for negative affect on Positive and Negative Affect Schedule (PANAS) test Completing the informed consent form 18 years 40 years Both Suffering any other major psychiatric illnesses Thyroid, immunological or neurological problems and other contraindications to Modafinil (such as refractory hypertension or history of cardiac arrhythmia) based on clinical history Mental retardation History of head injury or substance abuse F33.0 Major depressive disorder, recurrent, mild Treatment - Drugs Placebo The intervention group receive Modafinil for eight weeks in addition to standard antidepressant medication with SSRIs or SNRIs. The drug is initially administered for one week at dose of 100 mg/day and then continued at dose of 200 mg/day. Control group: the intervention group receive placebo for eight weeks in addition to standard antidepressant medication with SSRIs or SNRIs. Working memory capacity, measured by Persian word/non word span test. Timepoint: weeks 0, 2, 4 & 8 of drug administration. Method of measurement: Persian word/non word span test. Mashhad University of Medical Sciences Approved 2019-03-12 Ethics committee of Mashhad University of Medical Sciences Mashhad university of medical sciences, Daneshgah ST., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)