Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis

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.

Sponsors

Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Collaborator: Instituto de Salud Carlos III

Source Andalusian Network for Design and Translation of Advanced Therapies
Brief 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. 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.

Overall Status Unknown status
Start Date November 2012
Completion Date November 2015
Primary Completion Date November 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Risk of relapse 12 months
Enrollment 104
Condition
Intervention

Intervention Type: Drug

Intervention Name: Discontinuation antipsychotic treatment

Description: Dose reduction until withdrawal

Arm Group Label: Discontinuation antipsychotic treatment

Intervention Type: Drug

Intervention Name: Antipsychotic treatment

Description: Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice

Arm Group Label: Antipsychotic treatment

Other Name: Antipsychotic drugs

Eligibility

Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Miguel Ruiz Veguilla, MD, PhD Study Chair Virgen del Rocío Hospital
Overall Contact

Last Name: Clara M. Rosso Fernández, MD

Phone: 0034955013414

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Mental Health Unit Villamartín | Villamartín, Cádiz, 11650, Spain Recruiting José María Mongil San Juan, MD 0034956040209 [email protected] José María Mongil San Juan, MD Principal Investigator
Mental Health Unit Baza | Baza, Granada, 18800, Spain Recruiting Eva Bravo Barba, MD [email protected] Eva Bravo Barba, MD Principal Investigator
Mental Health Unit Motril | Motril, Granada, 18600, Spain Recruiting María Luisa Barrigón Estévez, MD 0034958038849 [email protected] María Luisa Barrigón Estévez, MD Principal Investigator
Mental Health Unit Andújar | Andújar, Jaén, 23740, Spain Recruiting Fernando Sarramea Crespo, MD, PhD 0034953021717 [email protected] Farnando Sarramea Crespo, MD, PhD Principal Investigator
Mental Health Unit Martos | Martos, Jaén, 23600, Spain Recruiting Miguel Ortigosa Luque, MD [email protected] Miguel Ortigosa Luque, MD Principal Investigator
Mental Health Unit Miraflores | Alcobendas, Madrid, 28100, Spain Not yet recruiting María Luisa Zamarro Arraz, MD, PhD 0034916530108 [email protected] María Luisa Zamarro Arraz, MD, PhD Principal Investigator
Hospital Infanta Sofía | San Sebastian de los Reyes, Madrid, 28702, Spain Not yet recruiting María Rosario Gutiérrez Labrador, MD [email protected] María Rosario Guitiérrez Labrador, MD Principal Investigator
Mental Health Unit Valle del Guadalhorce | Cártama, Málaga, 29580, Spain Not yet recruiting Daniel Gutiérrez Castillo, MD 0034951033931 [email protected] Daniel Gutiérrez Castillo, MD Principal Investigator
Mental Health Unit Las Lagunas | Fuengiróla, Málaga, 29650, Spain Not yet recruiting María Isabel Osuna Carmona, MD [email protected] María Isabel Osuna Carmona, MD Principal Investigator
Fundación Argibide | Pamplona, Navarra, 31007, Spain Not yet recruiting Ignacio Mata Pastor, MD, PhD 0034948266650 [email protected] Ignacio Mata Pastor, MD, PhD Principal Investigator
Hospital El Tomillar | Dos Hermanas, Seville, 41700, Spain Recruiting Joaquín Carlos Martín Muñoz, MD, PhD 0034955016083 [email protected] Joaquín Carlos Martín Muñoz, MD, PhD Principal Investigator
Hospital Francesc de Borja | Gandía, Valencia, 46700, Spain Recruiting María Lacruz Silvestre, MD, PhD [email protected] María Lacruz Silvestre, MD, PhD Principal Investigator
Hospital de Basurto | Bilbao, 48013, Spain Not yet recruiting Sonia Bustamante Madariaga, MD, Phd 0034944 006137 [email protected] Sonia Bustamante Madariaga, MD, PhD Principal Investigator
Mental Health Unit Tetuán | Madrid, 28003, Spain Not yet recruiting Mariano Hernández Monsalve, MD, PhD 0034915347363 [email protected] Mariano Hernández Monsalve, MD, PhD Principal Investigator
Lafora Hospital | Madrid, 28049, Spain Not yet recruiting Juan Dios Molina Martín, MD, PhD [email protected] Juan Dios Molina Martín, MD, PhD Principal Investigator
Hospital Carlos Haya | Málaga, 29009, Spain Recruiting Fermín Mayoral Cleríes, Md, PhD [email protected] Fermín Mayoral Cleríes, MD, PhD Principal Investigator
Virgen del Rocío Hospital | Seville, 41013, Spain Recruiting Clara M. Rosso Fernández, MD 0034955013414 [email protected] Miguel Ruiz Veguilla, MD, PhD Principal Investigator
Location Countries

Spain

Verification Date

December 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Antipsychotic treatment

Type: Active Comparator

Description: 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.

Label: Discontinuation antipsychotic treatment

Type: Experimental

Description: Dose reduction of antipsychotic treatment (25% every 4 weeks).

Acronym NONSTOP
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov