Guideline vs Usual Treatment in Schizophrenic Adolescents (ACER)

Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

Status: Completed

Conditions: Schizophrenia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02573701

II3/02/0811

Details and patient eligibility

About

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.

Full 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

Enrollment: 91 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

1 Guideline treatment

Experimental group

Description:

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"

Treatment:

Behavioral: "Psychosocial treatment"

Drug: Guideline treatment (Risperidone, administered orally)

2 Treatment as Usual

Active Comparator group

Description:

Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician

Treatment:

Drug: Treatment as Usual (any other antipsychotic)