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

• Sponsor: Fundación Marques de Valdecilla (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03090490
• Collaborator: Centro de Investigación Biomédica en Red de Salud Mental (Other), Instituto de Investigación Marqués de Valdecilla (Other)
• Enrollment: 68
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 75
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizophrenia Relapse; Schizophrenia Spectrum and Other Psychotic Disorders	Other: Antipsychotic treatment discontinuation; Other: Maintenance treatment discontinuation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 68 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Relapse rate [At 10 years]

   The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.

Secondary Outcome Measures

1. Change in general psychopathology measured by BPRS [At 10 years]

   Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).

2. Change in overall clinical status measured by CGI [At 10 years]

   Measured by changes in total score of the Clinical Global Impression (CGI).

3. Change in negative symptoms measured by SANS [At 10 years]

   Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS).

4. Change in negative symptoms measured by SAPS [At 10 years]

   Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS).

5. Time to relapse [At 10 years]

   Time to relapse in the two groups of patients, discontinuation and maintenance.

6. Functionality status measured by DAS [At 10 years]

   Measured by changes in total score of the Disability Assessment Scale (DAS).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Marques de Valdecilla	Santander	Cantabria	Spain	39008

Sponsors and Collaborators

• Fundación Marques de Valdecilla
• Centro de Investigación Biomédica en Red de Salud Mental
• Instituto de Investigación Marqués de Valdecilla

Investigators

• Principal Investigator: Benedicto Crespo-Facorro, Professor, University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benedicto Crespo-Facorro, Associate Professor of Psychiatry, Fundación Marques de Valdecilla
• ClinicalTrials.gov Identifier: NCT03090490
• Other Study ID Numbers: ADARFEP_10Y
• First Posted: Mar 24, 2017
• Last Update Posted: Jan 14, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Benedicto Crespo-Facorro, Associate Professor of Psychiatry, Fundación Marques de Valdecilla: Treatment; Maintenance
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Antipsychotic Agents

Study Results

No Results Posted as of Jan 14, 2020