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European Long-acting Antipsychotics in Schizophrenia Trial

NCT02146547 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2020-09-01

No results posted yet for this study

Summary

Schizophrenia is a chronic psychiatric illness with periods of remission and relapse. Patients vary in the frequency and severity of relapse, time until relapse and time in remission. Discontinuation of antipsychotic medication is by far the most important reason for relapse. A possible method to optimize medication adherence is to treat patients with long-term, depot medication rather than oral medication. However, despite its apparent "common sense" this approach has neither been universally accepted by practicing psychiatrists nor unequivocally demonstrated in clinical trials. Therefore, in this study we aim to investigate possible advantages of depot medication over oral antipsychotics in an independently designed and conducted, randomized, pragmatic trial.

Conditions

Interventions

DRUG

Aripiprazole

Administration in once-a-day schedule without regard to meals.

DRUG

Aripiprazole depot

Abilify Maintena is an intramuscular (IM) depot formulation of oral aripiprazole. It provides the efficacy and safety profile of oral aripiprazole in a once-monthly injection.

DRUG

Paliperidone

Administration once a day orally standardised in relation to food intake.

DRUG

Paliperidone palmitate

In selected patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilization with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable is needed.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Rene S Kahn, professor · UMC Utrecht

  • Wolfgang Fleischhacker, professor · Department of Biological Psychiatry, Innsbruck University Clinics

  • Michael Davidson, professor · Department of Psychiatry, Sackler Faculty of Medicine, Tel Aviv University, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2020-08-26
Completion
2020-08-26

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02146547 on ClinicalTrials.gov