SchizophreniaACERNCT02573701
Guideline vs Usual Treatment in Schizophrenic Adolescents
A study testing Guideline treatment (Risperidone, administered orally), "Psychosocial treatment" and Treatment as Usual (any other antipsychotic) in people with Schizophrenia, run by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Guideline treatment (Risperidone, administered orally), "Psychosocial treatment" and Treatment as Usual (any other antipsychotic)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Conditions
- Schizophrenia
- Being tested
- Guideline treatment (Risperidone, administered orally), "Psychosocial treatment", Treatment as Usual (any other antipsychotic)
- Keywords
- Schizophrenia, Adolescents, Treatment, Guidelines
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline treatment (Risperidone, administered orally)Drug
Also called Atypical antipsychotic
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"
"Psychosocial treatment"Behavioural
Also called "Psychoeducation", "Social Skills", "Healthy Life style", "Exercise in group"
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
Also called Any other antipsychotic assigned by clinician
Participants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician.
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: 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 Receives: Drug: Treatment as Usual (any other antipsychotic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: six months
Secondary outcomes (2)
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.
Measured: six months
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rosa E. Ulloa, Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
- Investigators
- Rosa E. Ulloa, Md Phd, Principal investigator, Secretaria de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573701
- Sponsor's protocol ID
- II3/02/0811
- Acronym
- ACER
- Status last verified
- Feb 2016
- First submitted
- 7 Oct 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02573701
- Acronym / sponsor ID
- ACER / II3/02/0811
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Adolescents, Treatment, Guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, MexicoOther government
- Study start
- Oct 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Guideline treatment | Experimental | Drug: Guideline treatment (Risperidone, administered orally), Behavioral: "Psychosocial treatment"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 | Drug: Treatment as Usual (any other antipsychotic)Participants will receive the Treatment as Usual (atypical antipsychotic) plus psychosocial treatment decided by clinician |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guideline treatment (Risperidone, administered orally)Also: Atypical antipsychoticParticipants 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 | 1 Guideline treatment |
| "Psychosocial treatment"Also: "Psychoeducation", "Social Skills", "Healthy Life style", "Exercise in group"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" | Behavioural | 1 Guideline treatment |
| Treatment as Usual (any other antipsychotic)Also: Any other antipsychotic assigned by clinicianParticipants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician. | Drug | 2 Treatment as Usual |
Primary outcome
Responder status, >30% reduction in PANSS score and improvement on CGI score.
Time frame: six months
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).
2 secondary outcomes
Functional outcomes assessed by the Personal and Social Performance Scale.
Time frame: six months
Cognition assessed using The MATRICS Consensus Cognitive Battery (MCCB)
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa E. Ulloa, Md Phd principal investigator
Secretaria de Salud
Questions about this trial
What is this clinical trial studying?
A study testing Guideline treatment (Risperidone, administered orally), "Psychosocial treatment" and Treatment as Usual (any other antipsychotic) in people with Schizophrenia, run by Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder status, >30% reduction in PANSS score and improvement on CGI score. (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.