10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals

Schizophrenia Clinical Trial

— ADARFEP_10Y  

Official title:

Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03090490
• Other study ID #: ADARFEP_10Y
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia Relapse
• Schizophrenia Spectrum and Other Psychotic Disorders

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