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Trial record 6 of 12 for:    "Somatoform Disorder" | "Serotonin Agents"

Assessment of Adverse Events in a Naive Pediatric Population Treated With an Antipsychotic

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ClinicalTrials.gov Identifier: NCT02007928
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

We propose a prospective multicenter study, whose originality lies in the inclusion of the naive child and adolescent population. Its purpose is to evaluate the incidence of adverse events related to the use of l antipsychotic drugs in children and adolescents with no history of taking such drugs.

The inclusion criteria will be: (1) male or female inpatients, (2) aged from 6 to 18 years, (3) requiring antipsychotic treatment, (4) receiving antipsychotic drug for less than 28 days without taking antipsychotic before or with a history of antipsychotic over a maximum period of three consecutive months and discontinued for at least 6 months.

Therapeutic monitoring during the 12 month study period will include clinical assessments and laboratory testing. These assessments will be performed before treatment (at inclusion), and at 1, 3, 6, 9, 12 months after the introduction of the antipsychotic drug.


Condition or disease Intervention/treatment Phase
Dissociative Disorders Schizophrenia Other: Rispéridone, aripiprazole, olanzapine Not Applicable

Detailed Description:
a prospective multicenter study, whose originality lies in the inclusion of the naive child and adolescent population

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Incidence of Adverse Events in a Naive Pediatric Population Treated With an (Typical and Atypical) Antipsychotic Drug Over 12 Months Follow-up
Study Start Date : April 2013
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
rispéridone, aripiprazole, olanzapine...

Study:

We propose a prospective, interventional multicenter study.

Method:

Both in and out patients may be included in the study Patients will be recruited over a period of 24 months. They will be followed up for 12 months. Each patient will receive one year of therapeutic monitoring after the introduction of the antipsychotic drug.

The therapeutic monitoring will include clinical, electrocardiographical, and laboratory assessments. These assessments are performed at baseline (before prescribing treatment) and at 1 month (M1), at 3 months (M3), 6 months (M6), 9 months (M9), and at 12 months (M12) after the first prescription of the antipsychotic drug.

Other: Rispéridone, aripiprazole, olanzapine

Study:

We propose a prospective, interventional multicenter study.

Method:

Both in and out patients may be included in the study Patients will be recruited over a period of 24 months. They will be followed up for 12 months. Each patient will receive one year of therapeutic monitoring after the introduction of the antipsychotic drug.

The therapeutic monitoring will include clinical, electrocardiographical, and laboratory assessments. These assessments are performed at baseline (before prescribing treatment) and at 1 month (M1), at 3 months (M3), 6 months (M6), 9 months (M9), and at 12 months (M12) after the first prescription of the antipsychotic drug.





Primary Outcome Measures :
  1. Clinical assessment and laboratory [ Time Frame: 12 months ]
    1. Clinical Assessment A: General assessment of adverse events by the Pediatric Adverse Event Rating Scale (PAERS-Clinician) (March et al, 2007). Performed at each visit.

      B: Somatic parameters to be monitored: weight, size, body mass index (BMI), abdominal perimeter, blood pressure, temperature. Performed at each visit.

      C: Electrocardiographic assessment of QT interval D: Neuromuscular adverse events: Abnormal Involuntary Movement Scale (AIMS) (Guy, 1976a), Barnes Akathisia Rating Scale (BARS) (Barnes, 1989), Simpson Angus Scale (SAS) (Simpson and Angus, 1970), Bush Francis Catatonia Rating Scale (BFCRS) (Bush and al, 1996),

    2. Laboratory assessments. The following laboratory tests will be obtained on each visit: complete blood count, liver enzymes, creatine phosphokinase, glycemia, cholesterol (total, light, and heavy), triglycerides, CRPus, prolactin, insulin, HOMA, HbA1C, vitamin D.


Secondary Outcome Measures :
  1. Risk Factors [ Time Frame: 12 months ]

    Tanner score of puberty at inclusion: population will be divided into three groups: prepubertal (stage ≤ 1); currently in puberty (stages 2 to 4) and puberty adult (stage 5).

    Drug history: age at initiation of treatment, the first-line atypical antipsychotic drug, other treatment(s), age of onset of disorder for which the prescription of an atypical antipsychotic drug was indicated.

    The diagnosis is made using the Schedule for Affective Disorders and Schizophrenia for School Age Children (Kiddie-SADS) (Kaufman and al, 1997).


  2. Persistence and/or reversibility of adverse events before the end of the study [ Time Frame: 12 months ]

    The investigators propose the following definitions for this study, based on published data and our preliminary study:

    • A persistent adverse event is an event that is still present 3 months after treatment cessation
    • A reversible adverse event is an event that has fully resolved 3 months after treatment cessation

  3. Scores [ Time Frame: 12 months ]

    4) Evaluation of the evolution of disorder severity at baseline, at M1, M3, M6, M9 and M12 The clinical severity of the disorder will be assessed using the Clinical Global Impressions Scales (CGI) (Guy, 1976b).

    5) Evaluation of the evolution of social functioning at baseline, at M6 and at M12 Social functioning will be assessed by the Child Global Assessment Scale (CGAS).

    6) Evaluation of the evolution of therapeutic alliance at M1, at M3, M6, M9 and at M12


  4. Quality of life [ Time Frame: 12 months ]
    7) Evaluation of the evolution of quality of life at baseline, at M1, M3, M6, M9 and at M12 Quality of life will be assessed by the Sheehan Disability Scale 8) The evaluation of the evolution of eating disorder at baseline, at M1, M3, M6, M9 and at M12 will be assessed by the Questionnaire of Eating and Weight Patterns 9) The evaluation of the evolution of physical activity at baseline, at M1, M3, M6, M9 and at M12 will be assessed by Dennison measure 10) Evaluation of the evolution of DSM diagnosis at baseline and at M12 by the Schedule for Affective Disorders and Schizophrenia for School Age Children (Kiddie-SADS)



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients
  • Aged from 6 to 18 years
  • In whom antipsychotic treatment is indicated
  • Who have never been treated with antipsychotic medication (other than metoclopramide (Primperan®) for pediatric indications) or with a history of antipsychotic over a maximum period of three consecutive months and discontinued for at least 6 months. .

The non-inclusion criteria:

  • Any

The exclusion criteria:

  • Refusal or withdrawal of consent by the patient or his/her parents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007928


Locations
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France
CH de Cannes
Cannes, Alpes-maritimes, France
Service de psychiatrie de l'enfant et de l'adolescent
Nice, Alpes-Maritimes, France, 06200
CH D'antibes
Antibes, Alpes-Maritime, France
CH Henri laborit
Poitiers, Charente Maritime, France, 86328
Fondation Vallée
Gentilly, Paris, France
Ch le Vinatier
Bron, France, 69678
CHRU de Lille
Lille, France
Centre Hospitalier Spécialisé Esquirol
Limoges, France
CH St Jean de Dieu
Lyon, France, 69355
HCL
Lyon, France
CHU de Nancy
Nancy, France
CHU de Nantes
Nantes, France
AP-HP
Paris, France
CHU de Toulouse
Toulouse, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Study Chair: MENARD Marie-Line, PH CHU de Nice - 52 avenue de la Californie 06 200 Nice

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02007928     History of Changes
Other Study ID Numbers: 12-PP-12
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Somatoform Disorders
Serotonin Agents
Schizophrenia
Dissociative Disorders
Conversion Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Aripiprazole
Antipsychotic Agents
Olanzapine
Serotonin Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents