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| Name | Class |
|---|---|
| Centro de Investigación Biomédica en Red de Salud Mental | NETWORK |
| Instituto de Investigación Marqués de Valdecilla | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Antipsychotic treatment discontinuation (DT) |
|
| Control group | Active Comparator | Maintenance antipsychotic treatment (MT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antipsychotic treatment discontinuation | Other | Withdrawal of antipsychotic medication to stabilized patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate | The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance. | At 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in general psychopathology measured by BPRS | Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS). | At 10 years |
| Change in overall clinical status measured by CGI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benedicto Crespo-Facorro, Professor | 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
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| Maintenance treatment discontinuation | Other | Maintenance antipsychotic medication to stabilized patients |
|
Measured by changes in total score of the Clinical Global Impression (CGI).
| 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). | 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). | At 10 years |
| Time to relapse | Time to relapse in the two groups of patients, discontinuation and maintenance. | At 10 years |
| Functionality status measured by DAS | Measured by changes in total score of the Disability Assessment Scale (DAS). | At 10 years |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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