Concomitant Administration of the Methylphenidate and Amantadine

Phase 3

Conditions: moderate to severe Traumatic Brain Injury.

Registration Number: IRCT20130310012776N7

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures