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

Schizophrenia Clinical Trial

— ADARFEP  

Official title:

Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: A 3-year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220504
• Other study ID #: ADARFEP
• 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
• 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.

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 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.