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IRCT20090117001556N141 IRCT 2022-03-01 Tehran University of Medical Sciences Lumateperone as adjuvant therapy for major depressive disorder Lumateperone as adjuvant therapy to sertraline in major depressive disorder: A randomized double blind and placebo controlled clinical trial 2022-04-21 anticipated 50 Complete https://irct.ir/trial/62228 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups), Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 Major depressive disorder. Intervention 1: Intervention group: received sertraline at a dose of 100 mg / day, and Lumateperone at a dose of 42 mg / day for 8 weeks. Intervention 2: Control group: received sertraline at a dose of 100 mg / day and placebo. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2022 to 2027 To whom: academic researchers Conditions: users should cite the resource of data Where to obtain: Prof Shahin Akhondzadeh How to obtain: by E mail Comments:
public Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Based on DSM-V have a diagnosis of major depression (MDD) and their minimum severity of depression based on HDRS is 19 Age between 18-65 18 years 65 years Both Any other mental disorder in another axis Serious suicidal thoughts (<2 in suicidal HDRS section) Psychosis History of ECT in recent two months History of mania and hypomania Thyroid dysfunctions History of cardiovascular disease Diabetes Autoimmune disorders Presence of active infection Neurologic disorders like epilepsy and Alzheimer's disease Liver disease Kidney disease Pregnant or lactating women F32 Major depressive disorder, single episode Treatment - Drugs Placebo Intervention group: received sertraline at a dose of 100 mg / day, and Lumateperone at a dose of 42 mg / day for 8 weeks. Control group: received sertraline at a dose of 100 mg / day and placebo. Severity of depression. Timepoint: Weeks 0 - 4 - 8. Method of measurement: by Hamiltion Depression Rating Scale. Tehran University of Medical Sciences Approved 2021-12-05 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)