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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Discontinuation antipsychotic treatment | Experimental | Dose reduction of antipsychotic treatment (25% every 4 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discontinuation antipsychotic treatment | Drug | Dose reduction until withdrawal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara M. Rosso Fernández, MD | Contact | 0034955013414 | claram.rosso.sspa@juntadeandalucia.es | |
| Miguel Ruiz Veguilla, MD, PhD | Contact | 0034955013414 | mruizveguilla@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Ruiz Veguilla, MD, PhD | Virgen del Rocío Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Basurto | Not yet recruiting | Bilbao | Bilbao | 48013 | Spain |
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| Antipsychotic treatment | Drug | Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice |
|
|
| Mental Health Unit Villamartín | Recruiting | Villamartín | Cádiz | 11650 | Spain |
|
| Mental Health Unit Baza | Recruiting | Baza | Granada | 18800 | Spain |
|
| Mental Health Unit Motril | Recruiting | Motril | Granada | 18600 | Spain |
|
| Mental Health Unit Andújar | Recruiting | Andújar | Jaén | 23740 | Spain |
|
| Mental Health Unit Martos | Recruiting | Martos | Jaén | 23600 | Spain |
|
| Mental Health Unit Miraflores | Not yet recruiting | Alcobendas | Madrid | 28100 | Spain |
|
| Mental Health Unit Tetuán | Not yet recruiting | Madrid | Madrid | 28003 | Spain |
|
| Lafora Hospital | Not yet recruiting | Madrid | Madrid | 28049 | Spain |
|
| Hospital Infanta Sofía | Not yet recruiting | San Sebastián de los Reyes | Madrid | 28702 | Spain |
|
| Mental Health Unit Valle del Guadalhorce | Not yet recruiting | Cártama | Málaga | 29580 | Spain |
|
| Mental Health Unit Las Lagunas | Not yet recruiting | Fuengiróla | Málaga | 29650 | Spain |
|
| Hospital Carlos Haya | Recruiting | Málaga | Málaga | 29009 | Spain |
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| Fundación Argibide | Not yet recruiting | Pamplona | Navarre | 31007 | Spain |
|
| Hospital El Tomillar | Recruiting | Dos Hermanas | Seville | 41700 | Spain |
|
| Virgen del Rocío Hospital | Recruiting | Seville | Seville | 41013 | Spain |
|
| Hospital Francesc de Borja | Recruiting | Gandia | Valencia | 46700 | Spain |
|
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D000077152 | Olanzapine |
| D003006 | Clopenthixol |
| C084602 | clothiapine |
| D005475 | Flupenthixol |
| D018967 | Risperidone |
| D013469 | Sulpiride |
| D014268 | Trifluoperazine |
| D006220 | Haloperidol |
| D000069348 | Quetiapine Fumarate |
| D000068882 | Paliperidone Palmitate |
| D002746 | Chlorpromazine |
| C084783 | pipothiazine |
| C084584 | periciazine |
| D003024 | Clozapine |
| D010868 | Pimozide |
| D010546 | Perphenazine |
| C066304 | sertindole |
| D008728 | Methotrimeprazine |
| D000077582 | Amisulpride |
| C522667 | asenapine |
| D063325 | Tiapride Hydrochloride |
| D004329 | Droperidol |
| C092292 | ziprasidone |
| D014150 | Antipsychotic Agents |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D013892 | Thioxanthenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010640 | Phenothiazines |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D003984 | Dibenzazepines |
| D001562 | Benzimidazoles |
| D005021 | Ethylamines |
| D000588 | Amines |
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |
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