10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals (ADARFEP_10Y)

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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia Relapse
• Intervention / Treatment: Other: Antipsychotic treatment discontinuation; Other: Maintenance treatment discontinuation

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • University Hospital Marqués de Valdecilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Antipsychotic treatment discontinuation (DT)	Other: Antipsychotic treatment discontinuation; Withdrawal of antipsychotic medication to stabilized patients
Active Comparator: Control group; Maintenance antipsychotic treatment (MT)	Other: Maintenance treatment discontinuation; Maintenance antipsychotic medication to stabilized patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse rate	The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.	At 10 years

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fundación Marques de Valdecilla
• Collaborators: Centro de Investigación Biomédica en Red de Salud Mental; Instituto de Investigación Marqués de Valdecilla

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Treatment; Maintenance
• Additional Relevant MeSH Terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antipsychotic Agents
• Other Study ID Numbers: ADARFEP_10Y

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No