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Completed

NCT Number: NCT02220504

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Relapse Schizophrenia Spectrum and Other Psychotic Disorders

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antipsychotic treatment discontinuation

Other

Withdrawal of antipsychotic medication to stabilized patients.

Maintenance antipsychotic treatment

Other

Maintenance antipsychotic medication to stabilized patients.

Primary outcomes

  1. Relapse rate.

    Time frame: At 3 years.

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

Secondary outcomes

  1. Clinical psychopathology.

    Time frame: At 3 years.

    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.

  2. Time to relapse.

    Time frame: At 3 years.

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

  3. Clinical functionality.

    Time frame: At 3 years.

Sponsors and collaborators

Lead sponsor

Fundación Marques de Valdecilla

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ADARFEP

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Aug 20, 2014
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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