PsychosisAGES-CMNCT02101372
Intervention Module AGES
A study testing treatment as usual and Psychoeducation group treatment in people with Psychosis, run by Celso Arango at 1 site in Spain.
Trial summary
The AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events (prospective- and retrospectively assessed) and the association of the interactions with… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Psychosis
- What is being tested?
- treatment as usual and Psychoeducation group treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jul 2014
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The presence of at least one positive psychotic symptom (delusions or hallucinations)
- Before age 18 diagnosed by DSM-IV
- Aged between 14 and 19 years and lived at home with 1 or both parents, caregivers, or legal guardians.
Who cannot join
- The exclusion criteria were patient's drug abuse or dependence at the time of the intervention (drug use was not an exclusion criterion), the presence of any neurological developmental disorder or mental retardation and inability to engage in conversation or read in Spanish that may interfere with the progress of group treatment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital general Universitario Gregorio Marañón
Madrid, Madrid, 28007
About this study
Official title: Gene and Environment in Schizophrenia- Research Groups in Madrid
The AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events (prospective- and retrospectively assessed) and the association of the interactions with structural and functional brain measures, neuropsychological performance, biochemical and oxidative status in both in patients and controls. The investigators study aimed to examine the effectiveness of a parallel, structured, and specific psychoeducational group intervention (PE) for adolescent patients and their families by comparing it with treatment as usual).
Read the detailed description
Objective: To assess the effectiveness of a structured psychoeducational group intervention for adolescents with early onset psychosis and their families. The intervention was implemented in parallel in 2 separate groups, by focusing specifically on problem solving strategies and structured psychosis-related information to manage daily life hassles associated with the disease in order to manage crises and prevent relapses.
Method: The investigators performed a 9-month, randomized, rater-blind clinical trial involving adolescent patients with early onset psychosis and 1 or both of their parents. The primary outcomes were number of hospitalizations, days of hospitalization, and visits to the emergency department. The secondary outcome measures were clinical variables and family environment and well being.
- Conditions
- Psychosis
- Being tested
- treatment as usual, Psychoeducation group treatment
- Keywords
- first episode psychosis, psychoeducation, group therapy
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment as usualBehavioural
case management
Psychoeducation group treatmentBehavioural
Psychoeducation therapy problem solving focus
| Study group | Role | What they receive |
|---|---|---|
| treatment as usual | Active comparator | Not described Receives: Behavioral: treatment as usual |
| Psychoeducation Group | Experimental | Not described Receives: Behavioral: Psychoeducation group treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of relapses
Measured: Change from baseline to 1 -year follow-up and 2 years follow-up
Secondary outcomes (1)
clinical severity
PANSS, CGAS, GAF, CGI-I
Measured: 1year 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celso Arango
- Sponsor type
- University, hospital or other
- Collaborators
- Comunidad de Madrid
- Responsible party
- Sponsor-investigator, Celso Arango, Hospital General Universitario Gregorio Marañon
- Investigators
- Celso Arango, MD, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101372
- Sponsor's protocol ID
- P2010/BMD-2422
- Acronym
- AGES-CM
- Status last verified
- Oct 2015
- First submitted
- 18 Mar 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Psychoeducational Group Intervention for Adolescents With Psychosis and Their Families: A Two-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):984-90. doi: 10.1016/j.jaac.2015.09.018. Epub 2015 Oct 13.
PubMed 26598473Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Intervention for adolescents with early-onset psychosis and their families: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):688-96. doi: 10.1016/j.jaac.2014.04.004. Epub 2014 Apr 18.
PubMed 24839887
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene and Environment in Schizophrenia- Research Groups in Madrid
- ClinicalTrials.gov ID
- NCT02101372
- Acronym / sponsor ID
- AGES-CM / P2010/BMD-2422
- Conditions
- Psychosis
- Keywords
- first episode psychosis, psychoeducation, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Celso ArangoUniversity, hospital or other
- Collaborators
- Comunidad de Madrid
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Apr 2014 (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 AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events (prospective- and retrospectively assessed) and the association of the interactions with structural and functional brain measures, neuropsychological performance, biochemical and oxidative status in both in patients and controls. The investigators study aimed to examine the effectiveness of a parallel, structured, and specific psychoeducational group intervention (PE) for adolescent patients and their families by comparing it with treatment as usual).
Detailed description
Objective: To assess the effectiveness of a structured psychoeducational group intervention for adolescents with early onset psychosis and their families. The intervention was implemented in parallel in 2 separate groups, by focusing specifically on problem solving strategies and structured psychosis-related information to manage daily life hassles associated with the disease in order to manage crises and prevent relapses.
Method: The investigators performed a 9-month, randomized, rater-blind clinical trial involving adolescent patients with early onset psychosis and 1 or both of their parents. The primary outcomes were number of hospitalizations, days of hospitalization, and visits to the emergency department. The secondary outcome measures were clinical variables and family environment and well being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment as usual | Active comparator | Behavioral: treatment as usual |
| Psychoeducation Group | Experimental | Behavioral: Psychoeducation group treatment |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- The presence of at least one positive psychotic symptom (delusions or hallucinations)
- Before age 18 diagnosed by DSM-IV
- Aged between 14 and 19 years and lived at home with 1 or both parents, caregivers, or legal guardians.
Key exclusion criteria (1 listed)
- The exclusion criteria were patient's drug abuse or dependence at the time of the intervention (drug use was not an exclusion criterion), the presence of any neurological developmental disorder or mental retardation and inability to engage in conversation or read in Spanish that may interfere with the progress of group treatment.
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 |
|---|---|---|
| treatment as usualcase management | Behavioural | treatment as usual |
| Psychoeducation group treatmentPsychoeducation therapy problem solving focus | Behavioural | Psychoeducation Group |
Primary outcome
number of relapses
Time frame: Change from baseline to 1 -year follow-up and 2 years follow-up
1 secondary outcome
clinical severity
Time frame: 1year 2 years
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 7 Oct 2015.
- Derived from this study: PubMed 26598473Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Psychoeducational Group Intervention for Adolescents With Psychosis and Their Families: A Two-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):984-90. doi: 10.1016/j.jaac.2015.09.018. Epub 2015 Oct 13.
- Derived from this study: PubMed 24839887Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Intervention for adolescents with early-onset psychosis and their families: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):688-96. doi: 10.1016/j.jaac.2014.04.004. Epub 2014 Apr 18.
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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.
Celso Arango, MD, PhD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment as usual and Psychoeducation group treatment in people with Psychosis, run by Celso Arango at 1 site in Spain.
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 1 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 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
number of relapses (time frame: Change from baseline to 1 -year follow-up and 2 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02101372, which also lists 2 linked publications.
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 7 Oct 2015.