Guideline vs Usual Treatment in Schizophrenic Adolescents (ACER)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Guideline treatment (Risperidone, administered orally)
"Psychosocial treatment"
Treatment as Usual (any other antipsychotic)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Adolescents, Treatment, Guidelines
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 Guideline treatment
2 Treatment as Usual
Arm 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"
Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02573701
First Posted
October 7, 2015
Last Updated
February 17, 2016
Sponsor
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT02573701
Brief Title
Guideline vs Usual Treatment in Schizophrenic Adolescents
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Adolescents, Treatment, Guidelines
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Guideline treatment
Arm Type
Experimental
Arm 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"
Arm Title
2 Treatment as Usual
Arm Type
Active Comparator
Arm Description
Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician
Intervention Type
Drug
Intervention Name(s)
Guideline treatment (Risperidone, administered orally)
Other Intervention Name(s)
Atypical antipsychotic
Intervention 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"
Intervention Type
Behavioral
Intervention Name(s)
"Psychosocial treatment"
Other Intervention Name(s)
"Psychoeducation", "Social Skills", "Healthy Life style", "Exercise in group"
Intervention 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"
Intervention Type
Drug
Intervention Name(s)
Treatment as Usual (any other antipsychotic)
Other Intervention Name(s)
Any other antipsychotic assigned by clinician
Intervention Description
Participants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician.
Primary Outcome Measure Information:
Title
Responder status, >30% reduction in PANSS score and improvement on CGI score.
Description
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
Secondary Outcome Measure Information:
Title
Functional outcomes assessed by the Personal and Social Performance Scale.
Description
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
Title
Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa E. Ulloa, Md Phd
Organizational Affiliation
Secretaria de Salud
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Guideline vs Usual Treatment in Schizophrenic Adolescents
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