Clinical trial NCT02462109: Catatonia in Nodding Syndrome and Lorazepam Treatment
Official title: Catatonia in Ugandan Children With Nodding Syndrome and Effects of Treatment With Lorazepam: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Catatonia
Nodding Syndrome
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of Mississippi Medical Center
First posted: 2015-06-03
Enrollment: 16
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Measured at 60 minutes after first dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Makerere University College of Health Sciences, Kampala, Uganda
name: Angelina Kakooza-Mwesige, MMed
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center, Jackson, USA
name: Dirk M Dhossche, MD, PhD
role: STUDY_DIRECTOR
References:
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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.
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.
citation: Dhossche DM. Decalogue of catatonia in autism spectrum disorders. Front Psychiatry. 2014 Nov 6;5:157. doi: 10.3389/fpsyt.2014.00157. eCollection 2014. No abstract available.
citation: Kakooza-Mwesige A, Dhossche DM, Idro R, Akena D, Nalugya J, Opar BT. Catatonia in Ugandan children with nodding syndrome and effects of treatment with lorazepam: a pilot study. BMC Res Notes. 2015 Dec 28;8:825. doi: 10.1186/s13104-015-1805-5.