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Completed

NCT Number: NCT02573701

Guideline vs Usual Treatment in Schizophrenic Adolescents

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guideline treatment (Risperidone, administered orally)

Drug

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"

Other names: Atypical antipsychotic

"Psychosocial treatment"

Behavioral

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"

Other names: "Psychoeducation", "Social Skills", "Healthy Life style", "Exercise in group"

Treatment as Usual (any other antipsychotic)

Drug

Participants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician.

Other names: Any other antipsychotic assigned by clinician

Primary outcomes

  1. Responder status, >30% reduction in PANSS score and improvement on CGI score.

    Time frame: six months

    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 outcomes

  1. Functional outcomes assessed by the Personal and Social Performance Scale.

    Time frame: six months

    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.

  2. Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB)

    Time frame: six months

    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.

Sponsors and collaborators

Lead sponsor

Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

Other Gov

Registry information

Official study 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

Acronym: ACER

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 12, 2015
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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