Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Intervention: Lithium Carbonate; Placebo
Intervention description: The subject start at a dosage regime of three times a day and one tablet of lithium carbonate, 250mg/table, oral administration each time for three days. The daily dose will be adjusted according to the serum lithium level and the clinical findings. Target serum lithium level is 0.6-1.2mM.
The course of medication is 6 weeks.; Matching placebo
Intervention MeSH terms: Lithium Carbonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Spinal Cord Injury

Summary:

      This is a randomized, placebo-controlled, double-blinded trial. Forty patients will be
      randomized into two groups. The subjects in the Treatment Group will be administered with
      lithium carbonate, while the Control Group will receive placebo.

      Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment
      group, the dose will be adjusted according to the serum lithium level while in the control
      group there will be a sham adjustment.

      The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The
      outcomes will be compared with baseline pre-treatment data to obtain "neurological change
      scores." The efficacy and safety will be analyzed comparing the results of the treatment
      group with those of the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender and 18-60 years of age;

          -  Subjects with chromic spinal cord injury (defined as a history of spinal cord injury
             for 12 months or longer);

          -  Subjects with ASIA - classification of A, B, or C for at least 6 months unchanged;

          -  Spinal cord injury vertebral level should be between C4 and T10;

          -  Subjects must be able to read, understand, and complete the VAS;

          -  Subjects who have voluntarily signed and dated an informed consent form, approved by
             an IRB/IEC, prior to any study specific procedures.

        Exclusion Criteria:

          -  A history of hypersensitivity or other adverse reaction to lithium;

          -  Significant renal, cardiovascular, hepatic and psychiatric disease;

          -  Significant medical diseases or infection;

          -  Addison's disease;

          -  Debilitation or dehydration;

          -  Recently taken or are taking diuretics or other drugs with known interaction with
             lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines;

          -  A history of alcohol abuse or drug abuse;

          -  Pregnant or lactating women;

          -  Female of childbearing potential and are unwilling to use an effective contraceptive
             method while enrolled in the study;

          -  Subjects who are currently participating in another investigational study or has been
             taking any investigational drug within the last 4 weeks prior to screening of this
             study;

          -  Subjects who have taken lithium for manic depression or other psychiatric
             conditions,and finally;

          -  Any criteria, which, in the opinion of the investigator, suggests that the subject
             would not be compliant with the study protocol.