Catatonia Clinical Trial
— CINSOfficial title:
Catatonia in Ugandan Children With Nodding Syndrome and Effects of Treatment With Lorazepam: A Pilot Study
Verified date | June 2015 |
Source | Makerere University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Uganda: National Council for Science and Technology |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 21 Years |
Eligibility |
Inclusion Criteria: 1. Children and adolescents with Nodding Syndrome as defined by the consensus definition agreed upon in the international Nodding Syndrome research meeting held in Kampala, Uganda July 2012. 2. Presence of two or more catatonic items on the Kampala Catatonia Panel. 3. Written informed consent from caregiver. Exclusion Criteria: 1. Children and adolescents with Nodding Syndrome who had a history of having used a benzodiazepine drug in the past 48 hours prior to intervention. 2. Children and adolescents with Nodding Syndrome who had a concurrent acute illness (e.g febrile illness, pneumonia) at time of assessment. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Makerere University | University of Mississippi Medical Center |
Dhossche DM. Decalogue of catatonia in autism spectrum disorders. Front Psychiatry. 2014 Nov 6;5:157. doi: 10.3389/fpsyt.2014.00157. eCollection 2014. Review. — View Citation
Kakooza-Mwesige A, Wachtel LE, Dhossche DM. Catatonia in autism: implications across the life span. Eur Child Adolesc Psychiatry. 2008 Sep;17(6):327-35. doi: 10.1007/s00787-008-0676-x. Epub 2008 Apr 21. Review. — View Citation
Sejvar JJ, Kakooza AM, Foltz JL, Makumbi I, Atai-Omoruto AD, Malimbo M, Ndyomugyenyi R, Alexander LN, Abang B, Downing RG, Ehrenberg A, Guilliams K, Helmers S, Melstrom P, Olara D, Perlman S, Ratto J, Trevathan E, Winkler AS, Dowell SF, Lwamafa D. Clinical, neurological, and electrophysiological features of nodding syndrome in Kitgum, Uganda: an observational case series. Lancet Neurol. 2013 Feb;12(2):166-74. doi: 10.1016/S1474-4422(12)70321-6. Epub 2013 Jan 8. — View Citation
Smith SL, Grelotti DJ, Fils-Aime R, Uwimana E, Ndikubwimana JS, Therosme T, Severe J, Dushimiyimana D, Uwamariya C, Bienvenu R, Alcindor Y, Eustache E, Raviola GJ, Fricchione GL. Catatonia in resource-limited settings: a case series and treatment protocol. Gen Hosp Psychiatry. 2015 Jan-Feb;37(1):89-93. doi: 10.1016/j.genhosppsych.2014.10.009. Epub 2014 Oct 30. — View Citation
Tibrewal P, Narayanaswamy J, Zutshi A, Srinivasaraju R, Math SB. Response rate of lorazepam in catatonia: a developing country's perspective. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Dec 1;34(8):1520-2. doi: 10.1016/j.pnpbp.2010.08.017. Epub 2010 Sep 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Measured at 60 minutes after first dose | No |
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