Clinical trial NCT02573701: Guideline vs Usual Treatment in Schizophrenic Adolescents
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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Adolescents
Treatment
Guidelines
Lead sponsor: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
Sponsor class: OTHER_GOV
First posted: 2015-10-12
Enrollment: 91
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Responder status, >30% reduction in PANSS score and improvement on CGI score.
timeFrame: six months
Secondary outcomes:
measure: Functional outcomes assessed by the Personal and Social Performance Scale.
timeFrame: six months
measure: Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: Secretaria de Salud
name: Rosa E. Ulloa, Md Phd
role: PRINCIPAL_INVESTIGATOR
References: