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

Sponsor

Fundación Pública Andaluza Progreso y Salud (Other)

Overall Status

Unknown status

CT.gov ID

NCT01765829

Collaborator

Instituto de Salud Carlos III (Other)

104

Enrollment

Locations

Arms

Duration (Months)

6.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychosis Nos/Other	Drug: Discontinuation antipsychotic treatment Drug: Antipsychotic treatment	Phase 3

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

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Nov 1, 2012

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Antipsychotic treatment 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.	Drug: Antipsychotic treatment Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice Other Names: Antipsychotic drugs
Experimental: Discontinuation antipsychotic treatment Dose reduction of antipsychotic treatment (25% every 4 weeks).	Drug: Discontinuation antipsychotic treatment Dose reduction until withdrawal Other Names: 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

Arm

Intervention/Treatment

Active Comparator: Antipsychotic treatment

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.

Drug: Antipsychotic treatment

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

Other Names:

Antipsychotic drugs

Experimental: Discontinuation antipsychotic treatment

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

Drug: Discontinuation antipsychotic treatment

Dose reduction until withdrawal

Other Names:

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

Outcome Measures

Primary Outcome Measures

Risk of relapse [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mental Health Unit Villamartín	Villamartín	Cádiz	Spain	11650
2	Mental Health Unit Baza	Baza	Granada	Spain	18800
3	Mental Health Unit Motril	Motril	Granada	Spain	18600
4	Mental Health Unit Andújar	Andújar	Jaén	Spain	23740
5	Mental Health Unit Martos	Martos	Jaén	Spain	23600
6	Mental Health Unit Miraflores	Alcobendas	Madrid	Spain	28100
7	Hospital Infanta Sofía	San Sebastian de los Reyes	Madrid	Spain	28702
8	Mental Health Unit Valle del Guadalhorce	Cártama	Málaga	Spain	29580
9	Mental Health Unit Las Lagunas	Fuengiróla	Málaga	Spain	29650
10	Fundación Argibide	Pamplona	Navarra	Spain	31007
11	Hospital El Tomillar	Dos Hermanas	Seville	Spain	41700
12	Hospital Francesc de Borja	Gandía	Valencia	Spain	46700
13	Hospital de Basurto	Bilbao		Spain	48013
14	Mental Health Unit Tetuán	Madrid		Spain	28003
15	Lafora Hospital	Madrid		Spain	28049
16	Hospital Carlos Haya	Málaga		Spain	29009
17	Virgen del Rocío Hospital	Seville		Spain	41013