Clinical Trial: Catatonia in Nodding Syndrome and Lorazepam Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Catatonia in Ugandan Children With Nodding Syndrome and Effects of Treatment With Lorazepam: A Pilot Study
Brief Summary: Nodding Syndrome is an enigmatic neuropsychiatric syndrome affecting children and adolescents mostly in Eastern Africa. The symptoms of Nodding Syndrome and catatonia seem to overlap. The researchers' objectives in this study were to investigate the presence and types of catatonic symptoms in children with Nodding Syndrome and observe their response to one or two doses of lorazepam, the first-line treatment for catatonia.
Detailed Summary:
In this pilot study, the investigators examined a convenient sample of children and adolescents with Nodding Syndrome (NS) for catatonic symptoms using standardized criteria. The investigators also tested whether oral lorazepam (LZP) administered to those who qualified to have pediatric catatonia would alleviate symptoms. This was a cross-sectional descriptive study of catatonia in NS patients in Northern Uganda and an exploratory study of using one or two doses of lorazepam as a catatonia test.
All the children with confirmed NS that had 2 or more of symptoms of catatonia were recruited to undergo the catatonia test using oral Lorazepam EG® (n.v. Eurogenerics s.a. Brussels, Belgium) using the 1 mg formulation tablets. It was proposed to perform a catatonia test using Lorazepam (LZP) as first choice medication, as this is the medication that has been used most commonly in pediatric catatonia.
The amount of drug given was based on the weight of the child. The lower dose (0.5 mg) was used as starting dose for patients with <30 kg body weight, while the higher dose (1 mg) as the starting dose for patients with >30 kg body weight.
A positive response to a catatonia test consisted of a reduction in catatonic symptoms, 30 or 60 minutes later, by at least 50% .Positive responses were documented by video footage before and after administration of LZP.
If no response to the initial dose of LZP, was observed after one hour, a second administration of the same medication at double the dose was given. Catatonia was again assessed at 30 and 60 minutes thereafter. If no response was observed, the test was considered negative.
Sponsor: Makerere University
Current Primary Outcome: A positive catatonia test (>50% reduction in catatonia symptoms and signs) on the responses of the children and adolescents with Nodding Syndrome and catatonia to test doses of oral Lorazepam. [ Time Frame: Measured at 60 minutes after first dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Makerere University
Dates:
Date Received: May 28, 2015
Date Started: March 2013
Date Completion:
Last Updated: June 2, 2015
Last Verified: June 2015
