Schizophrenia Clinical Trial
— ACEROfficial 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
Verified date | February 2016 |
Source | Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | July 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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. | six months |
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