Guideline vs Usual Treatment in Schizophrenic Adolescents

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573701
• Other study ID #: II3/02/0811
• Status: Completed
• Phase: N/A
• First received: October 7, 2015
• Last updated: February 17, 2016
• Start date: October 2011
• Est. completion date: July 2015

Study information

• Verified date: February 2016
• Source: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• 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"

Behavioral:
• "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"

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	six months
Secondary	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.	six months
Secondary	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.	six months