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Guideline vs Usual Treatment in Schizophrenic Adolescents (ACER)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guideline treatment (Risperidone, administered orally)
"Psychosocial treatment"
Treatment as Usual (any other antipsychotic)
Sponsored by
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Adolescents, Treatment, Guidelines

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Total score ≥ 70 on the Positive and Negative Syndrome Scale (PANSS) and a score of at least 4 (moderate) on 3 of the follow core items (conceptual disorganization , hallucinatory behavior, suspiciousness, and unusual thought content).
  • Patients were required to have a score of ≥ 4 symptoms on the Clinical Global Impression Improvement Scale (CGI-S)
  • Had not received antipsychotic in proper doses/ a regular antipsychotic treatment for at least 4 weeks previous enrollment.

Exclusion Criteria:

  • Unstable medical conditions
  • Their diagnosis changed during the study
  • Had a history of substance dependence or substance use (except cannabis), -Females with pregnancy
  • Refusal to practice contraception during the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1 Guideline treatment

    2 Treatment as Usual

    Arm Description

    Participants will receive the Guideline Treatment (risperidone, administered orally) plus Behavioral Intervention: "psychosocial treatment" included "psychoeducation" "social skills" "healthy life style habits" "exercise in group"

    Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician

    Outcomes

    Primary Outcome Measures

    Responder status, >30% reduction in PANSS score and improvement on CGI score.
    Responder status, defined by >30% reduction in PANSS scores and significant improvement on the CGI score. CGI significant improvement defined as a score of 1 (very much improved), or 2 (much improved).

    Secondary Outcome Measures

    Functional outcomes assessed by the Personal and Social Performance Scale.
    Functional outcomes assessed by the Personal and Social Performance Scale. The lowest score represents lack of autonomy in the basic functioning and the highest score reflects excellent performance.
    Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB)
    Cognition assessed using "The MATRICS Consensus Cognitive Battery"; includes ten trials evaluating seven cognitive domains; processing speed, verbal learning and visual, verbal working memory and non-verbal reasoning and problem solving, sustained attention, and social cognition.

    Full Information

    First Posted
    October 7, 2015
    Last Updated
    February 17, 2016
    Sponsor
    Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02573701
    Brief Title
    Guideline vs Usual Treatment in Schizophrenic Adolescents
    Acronym
    ACER
    Official Title
    Comparative Study of Recommended Treatment for Schizophrenia Guideline Treatment vs Treatment as Usual in Child Psychiatric Hospital: Effect on Adherence, Efficacy on Symptoms, and Global Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the applicability and usefulness of the guideline treatment for diagnosis and treatment of adolescents with schizophrenia, also to evaluate the compliance to the treatment according to the guidelines, and to compare the treatment compliance, severity of illness and social functioning of patients treated according to guideline treatment vs patients with the treatment as usual on a six month follow up.
    Detailed Description
    The drug treatment of patients on the Guideline Treatment group followed an algorithm, where an atypical antipsychotic must be maintained during 6 weeks before the evaluation of medication change if the PANSS score did not show a reduction of 30% and the patients did not show functional improvement. Clozapine could be administered if two trials of antipsychotics were not effective. Benzodiazepines, antidepressants, anticholinergics or anticonvulsants were allowed for the treatment of comorbid disorders or side effects. The psychosocial treatment included psychoeducation (three 90 min sessions with the family and two 45 min sessions with the patients), followed by a seven 45 min sessions training on social skills which focused on verbal and non-verbal communication, as well as in conversation skills. Patients were also trained in healthy life style habits and were included on a 30 min of exercise in group. TAU included an antipsychotic and the psychosocial treatment decided by the clinician

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Schizophrenia, Adolescents, Treatment, Guidelines

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    91 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 Guideline treatment
    Arm Type
    Experimental
    Arm Description
    Participants will receive the Guideline Treatment (risperidone, administered orally) plus Behavioral Intervention: "psychosocial treatment" included "psychoeducation" "social skills" "healthy life style habits" "exercise in group"
    Arm Title
    2 Treatment as Usual
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician
    Intervention Type
    Drug
    Intervention Name(s)
    Guideline treatment (Risperidone, administered orally)
    Other Intervention Name(s)
    Atypical antipsychotic
    Intervention Description
    Participants will receive the Guideline Treatment (risperidone, administered orally) plus Behavioral Intervention: "psychosocial treatment" included "psychoeducation" "social skills" "healthy life style habits" "exercise in group"
    Intervention Type
    Behavioral
    Intervention Name(s)
    "Psychosocial treatment"
    Other Intervention Name(s)
    "Psychoeducation", "Social Skills", "Healthy Life style", "Exercise in group"
    Intervention Description
    Participants will receive the Guideline Treatment (risperidone, administered orally) plus Behavioral Intervention: "psychosocial treatment" included "psychoeducation" "social skills" "healthy life style habits" "exercise in group"
    Intervention Type
    Drug
    Intervention Name(s)
    Treatment as Usual (any other antipsychotic)
    Other Intervention Name(s)
    Any other antipsychotic assigned by clinician
    Intervention Description
    Participants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician.
    Primary Outcome Measure Information:
    Title
    Responder status, >30% reduction in PANSS score and improvement on CGI score.
    Description
    Responder status, defined by >30% reduction in PANSS scores and significant improvement on the CGI score. CGI significant improvement defined as a score of 1 (very much improved), or 2 (much improved).
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Functional outcomes assessed by the Personal and Social Performance Scale.
    Description
    Functional outcomes assessed by the Personal and Social Performance Scale. The lowest score represents lack of autonomy in the basic functioning and the highest score reflects excellent performance.
    Time Frame
    six months
    Title
    Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB)
    Description
    Cognition assessed using "The MATRICS Consensus Cognitive Battery"; includes ten trials evaluating seven cognitive domains; processing speed, verbal learning and visual, verbal working memory and non-verbal reasoning and problem solving, sustained attention, and social cognition.
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Total score ≥ 70 on the Positive and Negative Syndrome Scale (PANSS) and a score of at least 4 (moderate) on 3 of the follow core items (conceptual disorganization , hallucinatory behavior, suspiciousness, and unusual thought content). Patients were required to have a score of ≥ 4 symptoms on the Clinical Global Impression Improvement Scale (CGI-S) Had not received antipsychotic in proper doses/ a regular antipsychotic treatment for at least 4 weeks previous enrollment. Exclusion Criteria: Unstable medical conditions Their diagnosis changed during the study Had a history of substance dependence or substance use (except cannabis), -Females with pregnancy Refusal to practice contraception during the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rosa E. Ulloa, Md Phd
    Organizational Affiliation
    Secretaria de Salud
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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