SchizophreniaADARFEP_10YNCT03090490
10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
A study testing Antipsychotic treatment discontinuation and Maintenance treatment discontinuation in people with Schizophrenia and Schizophrenia Relapse, run by Fundación Marques de Valdecilla at 1 site in Spain.
Trial summary
This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Antipsychotic treatment discontinuation and Maintenance treatment discontinuation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to Dec 2020
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).
- A minimum of 18 months on antipsychotic treatment.
- Meeting clinical remission criteria for at least the 12 months prior to inclusion.
- Meeting the functional recovery criteria for at least the 6 months prior to inclusion.
- Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.
Who cannot join
- Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.
- Meeting DSM-IV criteria for mental retardation.
- Having a history of neurological disease or head injury.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital Marques de Valdecilla
Santander, Cantabria, 39008
About this study
Official title: Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up
This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.
- Conditions
- Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders
- Being tested
- Antipsychotic treatment discontinuation, Maintenance treatment discontinuation
- Keywords
- Treatment, Maintenance
- Medical subject headings
- Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antipsychotic treatment discontinuationOther
Withdrawal of antipsychotic medication to stabilized patients
Maintenance treatment discontinuationOther
Maintenance antipsychotic medication to stabilized patients
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Antipsychotic treatment discontinuation (DT) Receives: Other: Antipsychotic treatment discontinuation |
| Control group | Active comparator | Maintenance antipsychotic treatment (MT) Receives: Other: Maintenance treatment discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
Measured: At 10 years
Secondary outcomes (6)
Change in general psychopathology measured by BPRS
Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).
Measured: At 10 years
Change in overall clinical status measured by CGI
Measured by changes in total score of the Clinical Global Impression (CGI).
Measured: At 10 years
Change in negative symptoms measured by SANS
Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS).
Measured: At 10 years
Change in negative symptoms measured by SAPS
Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS).
Measured: At 10 years
Time to relapse
Time to relapse in the two groups of patients, discontinuation and maintenance.
Measured: At 10 years
Functionality status measured by DAS
Measured by changes in total score of the Disability Assessment Scale (DAS).
Measured: At 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startSep 2014
- Primary completionDec 2017
- Study completionDec 2020 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Marques de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
- Responsible party
- Principal investigator, Benedicto Crespo-Facorro, Fundación Marques de Valdecilla
- Investigators
- Benedicto Crespo-Facorro, Professor, Principal investigator, University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090490
- Sponsor's protocol ID
- ADARFEP_10Y
- Acronym
- ADARFEP_10Y
- Status last verified
- Jan 2020
- First submitted
- 14 Mar 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up
- ClinicalTrials.gov ID
- NCT03090490
- Acronym / sponsor ID
- ADARFEP_10Y / ADARFEP_10Y
- Conditions
- Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders
- Keywords
- Treatment, Maintenance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fundación Marques de ValdecillaUniversity, hospital or other
- Collaborators
- Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Mar 2017 (actual)
- 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.
This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Antipsychotic treatment discontinuationAntipsychotic treatment discontinuation (DT) |
| Control group | Active comparator | Other: Maintenance treatment discontinuationMaintenance antipsychotic treatment (MT) |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).
- A minimum of 18 months on antipsychotic treatment.
- Meeting clinical remission criteria for at least the 12 months prior to inclusion.
- Meeting the functional recovery criteria for at least the 6 months prior to inclusion.
- Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.
Key exclusion criteria (3 listed)
- Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.
- Meeting DSM-IV criteria for mental retardation.
- Having a history of neurological disease or head injury.
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 |
|---|---|---|
| Antipsychotic treatment discontinuationWithdrawal of antipsychotic medication to stabilized patients | Other | Intervention group |
| Maintenance treatment discontinuationMaintenance antipsychotic medication to stabilized patients | Other | Control group |
Primary outcome
Relapse rate
Time frame: At 10 years
The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
6 secondary outcomes
Change in general psychopathology measured by BPRS
Time frame: At 10 years
Change in overall clinical status measured by CGI
Time frame: At 10 years
Change in negative symptoms measured by SANS
Time frame: At 10 years
Change in negative symptoms measured by SAPS
Time frame: At 10 years
Time to relapse
Time frame: At 10 years
Functionality status measured by DAS
Time frame: At 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Benedicto Crespo-Facorro, Professor principal investigator
University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antipsychotic treatment discontinuation and Maintenance treatment discontinuation in people with Schizophrenia and Schizophrenia Relapse, run by Fundación Marques de Valdecilla 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. 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?
Results are not available in the source record.
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?
Relapse rate (time frame: At 10 years). 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 14 Jan 2020.