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IRCT20130310012776N7 IRCT 2021-11-23 Shiraz University of Medical Sciences Concomitant Administration of the Methylphenidate and Amantadine Evaluating the Effect of the Concomitant Administration of Methylphenidate and Amantadine on the TBI-related Outcomes: A Randomized, Double-blind, Placebo-controlled, Parallel trial 2022-01-01 anticipated 200 Complete https://irct.ir/trial/59894 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Included patients will be allocated randomly into the experiment and placebo groups via the blocked randomization method. A trained research assistant will use blocked randomization with block sizes of 4 with an equal probability to enroll the eligible patients to the experiment group (group A) and placebo (group B). Regarding the size of block 4, we have six possible combinations of group assignments, including AABB, ABAB, BAAB, BABA, BBAA, and ABBA. At first, the assistant will select one of these arrangements randomly, and the four eligible admitted patients would be assigned accordingly in each block. We will repeat this process many times to include the eligible patients, Blinding description: Although the patients will be informed of our primary objectives, they won’t know which drugs/ placebo they will receive. Well-trained nurses who are unaware of the study’s objectives and the drugs containing bottles will be recruited to give the medication/placebo to the patients. As the placebo's color, shape, and size were identical to our medications, their differentiations were only possible via a specific code imprinted on the bottles. The main researchers only know to which category the drugs (codes) belong. 3 moderate to severe Traumatic Brain Injury. Intervention 1: Intervention group: Methylphenidate and Amantadine (AMH) will be given to our intervention group. Dosage of Methylphenidate and AMH will be 20mg and 100mg, respectively, and be given at 7 AM and 2 PM. The treatment will be continued till two weeks or hospital discharge, or the patients become fully conscious.The participants will be evaluated on the first day (before starting the treatment), immediately after the end of the treatment, and six months after starting the experiment. Intervention 2: Control group: Only Placebo with the same color, size, and shape will be given to our Control Group. The Placebo interval was similar to that of the intervention group. The treatment will be continued till two weeks or hospital discharge, or the patients become fully conscious. The participants will be evaluated on the first day (before starting the treatment), immediately after the end of the treatment, and six months after starting the experiment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no more information is available
public Hosseinali Khalili
Shiraz Neurosciences Research Center, chamran hospital
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 1623 4508 khalili_h@sums.ac.ir Shiraz University of Medical Sciences scientific Hosseinali Khalili
Shiraz Neurosciences Research Center, chamran hospital
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 1623 4508 khalili_h@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Pure Blunt Traumatic Brain injury The motor component of Glasgow coma score 4 or 5 Parenchymal damage less than or equal to 10 cc Heart rate less than 100 beats/min on the recruitment time intensive care unit staying for at least 5 days 18 years no limit Both Having Multiple Trauma Penetrating Traumatic Brain Injuries High Cervical Cord Injuries(C1-C4) Need for neurosurgery intervention for any causes Severe Agitation Previous history of Hospital admission due to psychiatric problem Known case of Attention Deficit Hyperactivity Disorder Heart Rate more than120 beats/min without any systemic diseases Active cancer or chemoradiotherapy Ischemic Heart Diseases Glomerular Filtration Rate less than 60 ccs/min Pregnant women Cerebral Palsy Mental Retardation Positive Drug history of Taking Neuroleptics, or Selective Serotonin Reuptake Inhibitors, or Monoamine Oxidase Inhibitor, or Lithium salts, or Propofol, or Thiopental Involved in other clinical trials during the last three months Decline to participate Rehabilitation Rehabilitation Intervention group: Methylphenidate and Amantadine (AMH) will be given to our intervention group. Dosage of Methylphenidate and AMH will be 20mg and 100mg, respectively, and be given at 7 AM and 2 PM. The treatment will be continued till two weeks or hospital discharge, or the patients become fully conscious.The participants will be evaluated on the first day (before starting the treatment), immediately after the end of the treatment, and six months after starting the experiment Control group: Only Placebo with the same color, size, and shape will be given to our Control Group. The Placebo interval was similar to that of the intervention group. The treatment will be continued till two weeks or hospital discharge, or the patients become fully conscious. The participants will be evaluated on the first day (before starting the treatment), immediately after the end of the treatment, and six months after starting the experiment Intensive Care Unit Length of Stay. Timepoint: At the time of Discharge from intensive care unite. Method of measurement: Counting the days when the patients were admitted in the intensive care unit. Hospital Length of Stay. Timepoint: At the time of Discharge from Hospital. Method of measurement: Counting the days when the patients were admitted in the Hospital. Glasgow outcome scale. Timepoint: At the beginning of the Experiment, two weeks after starting the experiment (just after the end of the drug administration), 6 months after starting the experiment. Method of measurement: According to the Glasgow outcome scale. Taking the antipsychotic or antidepressant drugs. Timepoint: 6 months after starting the experiment. Method of measurement: Taking or not taking the drugs as well as the dosage will be reported. Shiraz University of Medical Sciences Approved 2021-10-18 Ethic Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Street, Shiraz Town Shiraz Fars Iran (Islamic Republic of)