]>
IRCT20180522039784N1 IRCT 2020-08-09 Karaj University of Medical Sciences Evaluation of the effect of Modafinil in the treatment of major depressive disorder Comparison of therapeutic effects of modafinil plus sertraline versus sertraline plus placebo in outpatient treatment of major depressive disorder: a clinical trial 2019-09-23 anticipated 50 Complete https://irct.ir/trial/49773 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the number of clinic's receipt (being even or odds) patients will be divided in two groups. Patients with even turns will be allocated to control group, Blinding description: We will give each patient a specific code, which neither physician or analysor won't know that which code belongs to which group. Using placebo similar in shape to modafinil, patients won't informed their group. After analysis, research's manager will replace codes with actual groups. 3 Major depressive disorder. Intervention 1: Intervention group: receiving 200 mg of Modafinil each 12 hours plus standard dose of Sertraline for 6 weeks. Intervention 2: Control group: receiving placebo every 12 hours plus standard dose of Sertraline for 6 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is I will be willing to share this information with researchers who are conducting larger studies.I will give data to vice chancellor for research
public Hamed Shabani
Dabestan street; Seyedkhandan
Tehran Iran (Islamic Republic of) 1631735361 +98 21 8846 7286 Pacino1373@yahoo.com Karaj University of Medical Sciences scientific Dr. Marzie Assare
Alborz University of Medical Sciences; Nabovvat blvd
Karaj Iran (Islamic Republic of) 1631735361 +98 21 8846 7286 hhsgdn@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Diagnosis of major depressive disorder Informed consent 18 years 60 years Both Diagnosis of bipolar mood disorder, ADHD or any underlying medical disease Use of any illicit drugs Use of any medication that interferes modafinil action Past history of suicide Past history of receiving ECT Pregnancy Daily use of more than 250 mg of caffeine F32 Major depressive disorder, single episode Treatment - Drugs Treatment - Drugs Intervention group: receiving 200 mg of Modafinil each 12 hours plus standard dose of Sertraline for 6 weeks. Control group: receiving placebo every 12 hours plus standard dose of Sertraline for 6 weeks. Fatigue severity. Timepoint: Before intervention and 6 weeks after initiation. Method of measurement: Fatigue severity scale. Mood cahnges. Timepoint: Before intervention and 6 weeks after initiation. Method of measurement: Beck's depression inventory. Drug side effects. Timepoint: Six weeks after intervention. Method of measurement: Obtaining history. Karaj University of Medical Sciences Approved 2019-09-22 Ethics Committee of Alborz University of Medical Sciences Imam hussain hospital; Mahdasht road karaj Alborz Iran (Islamic Republic of)