Psychosis Nos/OtherPhase 3NONSTOPNCT01765829
Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis
A Phase 3 study testing Discontinuation antipsychotic treatment and Antipsychotic treatment in people with Psychosis Nos/Other, run by Fundación Pública Andaluza Progreso y Salud at 17 sites in Spain.
Trial summary
The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psychosis Nos/Other
- What is being tested?
- Discontinuation antipsychotic treatment and Antipsychotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 17 sitesSpain
- Study dates
- Nov 2012to Nov 2015
- Phase
- Phase 3
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult age from 18 to 55 years old
- Non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform disorders, acute psychosis, other psychosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- Antipsychotic treatment for 12 months since clinical stabilization. Clinical stabilization is defined in case of admission by medical discharge (not including voluntary discharge). In case of voluntary discharge or no admission to hospital, clinical stabilization can be defined by the psychiatrist according to medical history and the information provided by the family.
- No changes in the antipsychotic doses in the last 4 months.
- No suicide attempts in the last 12 months.
- Patient who shows remission criteria.
- Signed informed consent form.
Who cannot join
- Patient who is not fluent in Spanish language
- Patient who takes mood stabilizers (Lithium, antiepileptic drugs...)
- Dependency on alcohol or other substances of abuse (cannabis, cocaine...)
- History of brain injury with loss of consciousness for more than 1 hour, stroke or other central nervous system disorders.
- Intelligence testing (IQ) less than 70.
- Suicide attempt from stabilization.
- Pregnancy or planning to become pregnant during the study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites, 17 recruiting
- Not yet recruiting
Mental Health Unit Miraflores
Alcobendas, Madrid, 28100
María Luisa Zamarro Arraz, MD, PhD, 0034916530108, zamarroluisa@yahoo.es
María Luisa Zamarro Arraz, MD, PhD
- Recruiting
Mental Health Unit Andújar
Andújar, Jaén, 23740
Fernando Sarramea Crespo, MD, PhD, 0034953021717, fernandosarramea@hotmail.com
Farnando Sarramea Crespo, MD, PhD
- Recruiting
Mental Health Unit Baza
Baza, Granada, 18800
Eva Bravo Barba, MD, eva.bravo.barba@gmail.com
Eva Bravo Barba, MD
- Not yet recruiting
Hospital de Basurto
Bilbao, Bilbao, 48013
Sonia Bustamante Madariaga, MD, Phd, 0034944 006137, sonia.bustamantemadariaga@osakidetza.net
Sonia Bustamante Madariaga, MD, PhD
- Not yet recruiting
Mental Health Unit Valle del Guadalhorce
Cártama, Málaga, 29580
Daniel Gutiérrez Castillo, MD, 0034951033931, dgutierrezcastillo@gmail.com
Daniel Gutiérrez Castillo, MD
- Recruiting
Hospital El Tomillar
Dos Hermanas, Seville, 41700
Joaquín Carlos Martín Muñoz, MD, PhD, 0034955016083, joaquinmartin@hotmail.com
Joaquín Carlos Martín Muñoz, MD, PhD
- Not yet recruiting
Mental Health Unit Las Lagunas
Fuengiróla, Málaga, 29650
María Isabel Osuna Carmona, MD, maribelosunac@hotmail.com
María Isabel Osuna Carmona, MD
- Recruiting
Hospital Francesc de Borja
Gandia, Valencia, 46700
María Lacruz Silvestre, MD, PhD, maria.lacruz.silvestre@gmail.com
María Lacruz Silvestre, MD, PhD
- Not yet recruiting
Mental Health Unit Tetuán
Madrid, Madrid, 28003
Mariano Hernández Monsalve, MD, PhD, 0034915347363, hergoico@gmail.com
Ruth Berdún Pe, MD, ruthberdun@yahoo.es
- Not yet recruiting
Lafora Hospital
Madrid, Madrid, 28049
Juan Dios Molina Martín, MD, PhD, jmolinamar@hotmail.com
Juan Dios Molina Martín, MD, PhD
- Recruiting
Hospital Carlos Haya
Málaga, Málaga, 29009
Fermín Mayoral Cleríes, Md, PhD, fermin.mayoral.sspa@juntadeandalucia.es
Fermín Mayoral Cleríes, MD, PhD
- Recruiting
Mental Health Unit Martos
Martos, Jaén, 23600
Miguel Ortigosa Luque, MD, migueortigosa@hotmail.com
Miguel Ortigosa Luque, MD
- Recruiting
Mental Health Unit Motril
Motril, Granada, 18600
María Luisa Barrigón Estévez, MD, 0034958038849, marial.barrigon.sspa@juntadeandalucia.es
María Luisa Barrigón Estévez, MD
- Not yet recruiting
Fundación Argibide
Pamplona, Navarre, 31007
Ignacio Mata Pastor, MD, PhD, 0034948266650, nacho.mata70@gmail.com
Ignacio Mata Pastor, MD, PhD
- Not yet recruiting
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
María Rosario Gutiérrez Labrador, MD, rosagutierrez@psiquiatra.e.telefonica.net
María Rosario Guitiérrez Labrador, MD
- Recruiting
Virgen del Rocío Hospital
Seville, Seville, 41013
Clara M. Rosso Fernández, MD, 0034955013414, claram.rosso.sspa@juntadeandalucia.es
Miguel Ruiz Veguilla, MD, PhD, 0034955013414, mruizveguilla@yahoo.com
- Recruiting
Mental Health Unit Villamartín
Villamartín, Cádiz, 11650
José María Mongil San Juan, MD, 0034956040209, cheman45@gmail.com
José María Mongil San Juan, MD
About this study
Official title: Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affective Psychosis.
The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes.
The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.
Read the detailed description
Randomized, open label, multicenter, phase III clinical trial. Number of subjects: 104. Age range: 18 - 55 years of both sex.
Timepoints for evaluation: Every two weeks, during the first six months after initiation of treatment discontinuation/continuation. Every four weeks during the remaining six months, to complete a total follow-up scheme of 12 months.
- Conditions
- Psychosis Nos/Other
- Being tested
- Discontinuation antipsychotic treatment, Antipsychotic treatment
- Keywords
- Non Affective Psychosis, First episode, Discontinuation scheme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation antipsychotic treatmentDrug
Also called Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine
Dose reduction until withdrawal
Antipsychotic treatmentDrug
Also called Antipsychotic drugs
Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Antipsychotic treatment | Active comparator | Antipsychotic treatment according to common clinical practice
Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine, Pipotiazine, Flufenazine, Periciazine, Clozapine, Pimozide, Perfenazine, Sertindole, Levomepromazine, Amisulpride, Asenapine, Tiapride, Droperidol, Ziprasidone. Receives: Drug: Antipsychotic treatment |
| Discontinuation antipsychotic treatment | Experimental | Dose reduction of antipsychotic treatment (25% every 4 weeks). Receives: Drug: Discontinuation antipsychotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of relapse
The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosis Nos/OtherStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Miguel Ruiz Veguilla, MD, PhD, Study chair, Virgen del Rocío Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765829
- Sponsor's protocol ID
- NONSTOP
- Acronym
- NONSTOP
- Status last verified
- Dec 2014
- First submitted
- 3 Jan 2013
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affective Psychosis.
- ClinicalTrials.gov ID
- NCT01765829
- Acronym / sponsor ID
- NONSTOP / NONSTOP
- Conditions
- Psychosis Nos/Other
- Keywords
- Non Affective Psychosis, First episode, Discontinuation scheme
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 10 Jan 2013 (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 is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes.
The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.
Detailed description
Randomized, open label, multicenter, phase III clinical trial. Number of subjects: 104. Age range: 18 - 55 years of both sex.
Timepoints for evaluation: Every two weeks, during the first six months after initiation of treatment discontinuation/continuation. Every four weeks during the remaining six months, to complete a total follow-up scheme of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic treatment | Active comparator | Drug: Antipsychotic treatmentAntipsychotic treatment according to common clinical practice Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine, Pipotiazine, Flufenazine, Periciazine, Clozapine, Pimozide, Perfenazine, Sertindole, Levomepromazine, Amisulpride, Asenapine, Tiapride, Droperidol, Ziprasidone. |
| Discontinuation antipsychotic treatment | Experimental | Drug: Discontinuation antipsychotic treatmentDose reduction of antipsychotic treatment (25% every 4 weeks). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult age from 18 to 55 years old
- Non-affective psychosis diagnosis (schizophrenia, schizoaffective, schizophreniform disorders, acute psychosis, other psychosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- Antipsychotic treatment for 12 months since clinical stabilization. Clinical stabilization is defined in case of admission by medical discharge (not including voluntary discharge). In case of voluntary discharge or no admission to hospital, clinical stabilization can be defined by the psychiatrist according to medical history and the information provided by the family.
- No changes in the antipsychotic doses in the last 4 months.
- No suicide attempts in the last 12 months.
Key exclusion criteria (7 listed)
- Patient who is not fluent in Spanish language
- Patient who takes mood stabilizers (Lithium, antiepileptic drugs...)
- Dependency on alcohol or other substances of abuse (cannabis, cocaine...)
- History of brain injury with loss of consciousness for more than 1 hour, stroke or other central nervous system disorders.
- Intelligence testing (IQ) less than 70.
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 |
|---|---|---|
| Discontinuation antipsychotic treatmentAlso: Aripiprazole, Olanzapine, Zuclopenthixol, ClotiapineDose reduction until withdrawal | Drug | Discontinuation antipsychotic treatment |
| Antipsychotic treatmentAlso: Antipsychotic drugsAntipsychotic treatment is not modify during the study, it is administered according to common clinical practice | Drug | Antipsychotic treatment |
Primary outcome
Risk of relapse
Time frame: 12 months
The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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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.
Miguel Ruiz Veguilla, MD, PhD study chair
Virgen del Rocío Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Discontinuation antipsychotic treatment and Antipsychotic treatment in people with Psychosis Nos/Other, run by Fundación Pública Andaluza Progreso y Salud at 17 sites 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 7 inclusion and 7 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Clara M. Rosso Fernández, MD (0034955013414, claram.rosso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of relapse (time frame: 12 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 5 Dec 2014.