Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
China Spinal Cord Injury Network
Collaborators:
Buddhist Tzu Chi General Hospital China Rehabilitation Research Center