Catatonia in Nodding Syndrome and Lorazepam Treatment (CINS)

Makerere University

Status and phase: Completed; Phase 1

Conditions: Catatonia; Nodding Syndrome

Treatments: Drug: Lorazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT02462109

HS 1330

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Lorazepam

Experimental group

Description:

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.

Treatment:

Drug: Lorazepam