Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia

Last updated: February 8, 2017
Sponsor: H. Lundbeck A/S
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Psychosis

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT01795547
14724A
2012-002785-12
  • Ages 18-60
  • All Genders

Study Summary

To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • The patient has schizophrenia, diagnosed according to DSM-IV-TR®.

  • The patient has a CGI-S score from mildly ill to markedly ill at the Screening andBaseline Visit(s).

  • The patient is in need of a change in the current antipsychotic treatment and in thejudgement of the investigator the patient would benefit from an extended treatmentwith a once-monthly formulation.

  • The patient agrees to protocol-defined use of effective contraception.

Exclusion

Main Exclusion Criteria:

  • The patient has any current psychiatric disorder or Axis I disorder (DSM-IV® criteria)other than schizophrenia established as the primary diagnosis.

  • The patient is experiencing acute exacerbation of psychotic symptoms at the ScreeningVisit or between the Screening and Baseline Visits.

  • The patient in the investigator's judgment has shown significant intolerance and/orlack of efficacy to oral aripiprazole, paliperidone or risperidone.

  • The patient is at significant risk of harming himself/herself or others according tothe investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).

  • The patient has a history of neuroleptic malignant syndrome.

  • The patient has or has had significant medical condition that would expose him or herto an undue risk of a significant adverse event or interfere with assessments ofsafety or efficacy during the course of the study including, but not limited toneurological, hepatic, renal, metabolic, haematological, immunological,gastrointestinal, pulmonary, or cardiovascular disorders.

  • The patient has a disease or takes medication that could, in the investigator'sopinion, interfere with the assessments of safety, tolerability, or efficacy, orinterfere with the conduct or interpretation of the study.

  • The patient is, in the investigator's opinion, unlikely to comply with the protocol oris unsuitable for any reason.

Study Design

Total Participants: 295
Study Start date:
February 01, 2013
Estimated Completion Date:
September 30, 2014

Connect with a study center

  • US002

    Los Angeles, California 90660
    United States

    Site Not Available

  • US006

    San Diego, California 92102
    United States

    Site Not Available

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