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IRCT20231017059749N1 IRCT 2023-10-21 Arak University of Medical Sciences The effect of injectable scopolamine in patients with major depressive disorders The augmentation effect of injectable scopolamine in the improvement of clinical symptoms of patients with major depressive disorder 2023-10-22 anticipated 46 Complete https://irct.ir/trial/73231 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomized block method will be used for randomization into two groups of scopolamine (group A) and treatment with standard treatment (group B). For this purpose, a block of 4 will be used. Four cards are selected, the letter A is written on two cards, and the letter B is written on the other two cards. In order to hide the cards, they are placed inside the envelope and turned over several times so that the order is not clear. When each participant enters, a card is selected for him and the selected card is discarded; This work is also done for the next patient to determine 4 people. Then, in the same way, randomization will be done for other groups of 4 people to reach the desired sample size. 3 Major depressive disorder. Intervention 1: Intervention group: In addition to standard treatment (SSRI), patients will receive 0.5 mg scopolamine intramuscularly daily for three days. Intervention 2: Intervention group: Patients will receive standard treatment (SSRI). Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2024/01/20 to 2027/01/20 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: Academic researchers and university professors can request the use of data from Dr. Ali Sabouri after contacting the relevant official via message or email. Dr. Ali Sabouri: Phone: 09126031453 Email: ali.sabouri1987@gmail.com Address: Arak, Amirkabir Hospital, Hospital Education Vice-Chancellor How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr Alireza Kmali
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences scientific Dr Mehran Shayeganfard
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
Arak Iran (Islamic Republic of) 3848176941 +98 86 3222 2003 mshayganfard@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients with major depressive disorder Age 18-55 years Minimum severity of depression based on Hamilton Depression Scale should be higher or equal to 20. 18 years 55 years Both The existence of psychotic disorder, delirium and bipolar disorderPregnancy or breastfeeding Taking psychedelic drugs, antidepressants in the last month ECT in the last two months History of cardiovascular disease Hypothyroidism F32 Major depressive disorder, single episode Treatment - Drugs Treatment - Drugs Intervention group: In addition to standard treatment (SSRI), patients will receive 0.5 mg scopolamine intramuscularly daily for three days. Intervention group: Patients will receive standard treatment (SSRI). Hamilton depression scale. Timepoint: The beginning of the study, the fourth day, the seventh day, the fourteenth day, the twenty-eighth day. Method of measurement: Hamilton questionnaire. Arak University of Medical Sciences Approved 2022-08-28 Ethics Committee of Arak University of Medical Sciences Vice chancellor for research, Arak University of Medical Sciences, Basij Square, Arak, Iran Arak Markazi Iran (Islamic Republic of)