Catatonia in Nodding Syndrome and Lorazepam Treatment

NCT02462109 | Completed Phase 1

• 1 other identifier: HS 1330
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Catatonia; Nodding Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lorazepam

EXPERIMENTAL

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

Interventions

Lorazepam DRUG

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

Lorazepam

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Presence of two or more catatonic items on the Kampala Catatonia Panel.
• Written informed consent from caregiver.

You may not qualify if:

• Children and adolescents with Nodding Syndrome who had a history of having used a benzodiazepine drug in the past 48 hours prior to intervention.
• Children and adolescents with Nodding Syndrome who had a concurrent acute illness (e.g febrile illness, pneumonia) at time of assessment.

Sponsors & Collaborators

• Makerere University: lead
• University of Mississippi Medical Center: collaborator

Related Publications (6)

• 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.

  PMID: 25467078 BACKGROUND

• 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.

  PMID: 20804808 BACKGROUND

• 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.

  PMID: 18427869 BACKGROUND

• 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.

  PMID: 23305742 BACKGROUND

• 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.

  PMID: 25414675 BACKGROUND

• 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.

  PMID: 26710961 DERIVED

MeSH Terms

Conditions

Catatonia; Nodding Syndrome

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Angelina Kakooza-Mwesige, MMed

  Makerere University College of Health Sciences, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

• Dirk M Dhossche, MD, PhD

  University of Mississippi Medical Center, Jackson, USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 3, 2015
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 3, 2015

Record last verified: 2015-06