Guideline vs Usual Treatment in Schizophrenic Adolescents

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Treatment as Usual (any other antipsychotic); Drug: Guideline treatment (Risperidone, administered orally); Behavioral: "Psychosocial treatment"

• Registration Number: NCT02573701
• Lead Sponsor: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

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

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Guideline treatment	"Psychosocial treatment"	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"
2 Treatment as Usual	Treatment as Usual (any other antipsychotic)	Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician
1 Guideline treatment	Guideline treatment (Risperidone, administered orally)	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"

Primary Outcome Measures

Name	Time	Method
Responder status, >30% reduction in PANSS score and improvement on CGI score.	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 Outcome Measures

Name	Time	Method
Functional outcomes assessed by the Personal and Social Performance Scale.	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.
Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB)	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.