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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03090490
Other study ID # ADARFEP_10Y
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date December 2020

Study information

Verified date January 2020
Source Fundación Marques de Valdecilla
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 68
Est. completion date December 2020
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria:

- Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).

- A minimum of 18 months on antipsychotic treatment.

- Meeting clinical remission criteria for at least the 12 months prior to inclusion.

- Meeting the functional recovery criteria for at least the 6 months prior to inclusion.

- Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.

Exclusion Criteria:

- Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.

- Meeting DSM-IV criteria for mental retardation.

- Having a history of neurological disease or head injury.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Antipsychotic treatment discontinuation
Withdrawal of antipsychotic medication to stabilized patients
Maintenance treatment discontinuation
Maintenance antipsychotic medication to stabilized patients

Locations

Country Name City State
Spain University Hospital Marques de Valdecilla Santander Cantabria

Sponsors (3)

Lead Sponsor Collaborator
Fundación Marques de Valdecilla Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse rate The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance. At 10 years
Secondary Change in general psychopathology measured by BPRS Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS). At 10 years
Secondary Change in overall clinical status measured by CGI Measured by changes in total score of the Clinical Global Impression (CGI). At 10 years
Secondary 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
Secondary 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
Secondary Time to relapse Time to relapse in the two groups of patients, discontinuation and maintenance. At 10 years
Secondary Functionality status measured by DAS Measured by changes in total score of the Disability Assessment Scale (DAS). At 10 years
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