search
Back to results

Catatonia in Nodding Syndrome and Lorazepam Treatment (CINS)

Primary Purpose

Catatonia, Nodding Syndrome

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lorazepam
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Catatonia

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lorazepam

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2015
    Last Updated
    June 2, 2015
    Sponsor
    Makerere University
    Collaborators
    University of Mississippi Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02462109
    Brief Title
    Catatonia in Nodding Syndrome and Lorazepam Treatment
    Acronym
    CINS
    Official Title
    Catatonia in Ugandan Children With Nodding Syndrome and Effects of Treatment With Lorazepam: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Makerere University
    Collaborators
    University of Mississippi Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Catatonia, Nodding Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lorazepam
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Lorazepam
    Other Intervention Name(s)
    Ativan
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angelina Kakooza-Mwesige, MMed
    Organizational Affiliation
    Makerere University College of Health Sciences, Kampala, Uganda
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Dirk M Dhossche, MD, PhD
    Organizational Affiliation
    University of Mississippi Medical Center, Jackson, USA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25467078
    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.
    Results Reference
    background
    PubMed Identifier
    20804808
    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.
    Results Reference
    background
    PubMed Identifier
    18427869
    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.
    Results Reference
    background
    PubMed Identifier
    23305742
    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.
    Results Reference
    background
    PubMed Identifier
    25414675
    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.
    Results Reference
    background
    PubMed Identifier
    26710961
    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.
    Results Reference
    derived

    Learn more about this trial

    Catatonia in Nodding Syndrome and Lorazepam Treatment

    We'll reach out to this number within 24 hrs