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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130310012776N7

Enrollment

200

Registered

2021-11-23

Start date

2022-01-01

Completion date

Unknown

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderate to severe Traumatic Brain Injury.

Interventions

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 a

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHosseinali Khalili

Shiraz University of Medical Sciences

khalili_h@sums.ac.ir+98 71 1623 4508

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026