A Phase 1 interventional study of Lorazepam in Catatonia and Nodding Syndrome, sponsored by Makerere University. Completed. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2015-06-03.
Sponsored by Makerere University · Phase 1, Interventional, and Supportive care
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.
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.
22 studies on the registry are indexed under Catatonia; 10 are open to participants now.
This study's enrollment of 16 is below the median of 63 across 14 interventional studies indexed under Catatonia.
Browse Catatonia studies →Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children with confirmed Nodding syndrome that had 2 or more of the symptoms on the 10-item Kampala Catatonia Panel (KCP) scale were recruited to undergo the catatonia test using oral Lorazepam EG® (n.v. Eurogenerics s.a. Brussels, Belgium) using the 1 mg formulation tablets. The amount of Lorazepam (LZP) drug given orally 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, 60 minutes later, by at least 50% assessed by the KCP (using all 10 items). 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 60 minutes thereafter. If no response was observed, the test was considered negative.
Drug: Lorazepam
Lorazepam was given based on the weight of the child with Catatonia. 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.
Also known as: Ativan
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
No study locations are listed for this record.
The record gives a start of Mar 2013, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lorazepam