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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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" |
|
| 2 Treatment as Usual | Active Comparator | Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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" |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | six months |
| Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa E. Ulloa, Md Phd | Secretaria de Salud | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 25, 2016 | |
| Reset | Dec 13, 2016 | |
| Release | Mar 17, 2017 | |
| Reset | Apr 27, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 25, 2016 | Dec 13, 2016 | |||
| Mar 17, 2017 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| D015444 | Exercise |
| D044382 | Population Groups |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| "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" |
|
|
| Treatment as Usual (any other antipsychotic) | Drug | Participants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician. |
|
|
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. |
| six months |
| Apr 27, 2017 |
| D009043 |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003710 | Demography |
| D011154 | Population Characteristics |