An interventional study of Guideline treatment (Risperidone, administered orally) and "Psychosocial treatment" in Schizophrenia, sponsored by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico. Completed. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico · Not applicable, Interventional, and Treatment
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.
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
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 91 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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: Guideline treatment (Risperidone, administered orally) · Behavioral: "Psychosocial treatment"
Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician
Drug: Treatment as Usual (any other antipsychotic)
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"
Also known as: Atypical antipsychotic
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"
Also known as: "Psychoeducation", "Social Skills", "Healthy Life style", "Exercise in group"
Participants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician.
Also known as: Any other antipsychotic assigned by clinician
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).
Time frame: six months
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.
Time frame: six months
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.
Time frame: six months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico