Guideline vs Usual Treatment in Schizophrenic Adolescents

NCT02573701 | Completed DMC

• 1 other identifier: II3/02/0811
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Adolescents; Treatment; Guidelines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional outcomes assessed by the Personal and Social Performance Scale.

  six months

• Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB)

  six months

Study Arms (2)

1 Guideline treatment

EXPERIMENTAL

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"

2 Treatment as Usual

ACTIVE COMPARATOR

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

Drug: Treatment as Usual (any other antipsychotic)

Interventions

Guideline treatment (Risperidone, administered orally) DRUG

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

1 Guideline treatment

"Psychosocial treatment" BEHAVIORAL

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"

1 Guideline treatment

Treatment as Usual (any other antipsychotic) DRUG

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

2 Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; Exercise; Population Groups; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Demography; Population Characteristics

Study Officials

• Rosa E. Ulloa, Md Phd

  Secretaria de Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator in Medical Sciences

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 12, 2015
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02