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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02220504
Other study ID # ADARFEP
Secondary ID
Status Completed
Phase N/A
First received August 13, 2014
Last updated March 13, 2017
Start date July 2004
Est. completion date July 2014

Study information

Verified date March 2017
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 three years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date July 2014
Est. primary completion date February 2014
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 antipsychotic treatment
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 main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance. At 3 years.
Secondary Clinical psychopathology. Clinical psychopathology differences between groups are evaluated by the mean change from the study intake to 3 years for the severity of Clinical Global Impression scale (CGI), Brief Psychiatric Rating Scale expanded version of 24 items (BPRS), Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS) total scores. At 3 years.
Secondary Time to relapse. Time to relapse in the two groups of patients, discontinuation and maintenance. At 3 years.
Secondary Clinical functionality. At 3 years.
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