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

Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Aripiprazole and aripiprazole once-monthly (Drug); Paliperidone and paliperidone palmitate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

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.

Clinical Details

Official title: A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean change from Baseline in quality of life

Secondary outcome:

Investigator's assessment of overall effectiveness

Mean change from Baseline in clinical global impression

Mean change from Baseline in quality of life using QLS

Mean change from Baseline in subjective well-being using SWN-S

Mean change from Baseline in tolerability and quality of life using TooL

Safety and tolerability

Risk of suicidality

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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 and

Baseline Visit(s).

- The patient is in need of a change in the current antipsychotic treatment and in the

judgement of the investigator the patient would benefit from an extended treatment with a once-monthly formulation.

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

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 Screening

Visit or between the Screening and Baseline Visits.

- The patient in the investigator's judgment has shown significant intolerance and/or

lack of efficacy to oral aripiprazole, paliperidone or risperidone.

- The patient is at significant risk of harming himself/herself or others according to

the 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 any relevant medical history or current presence of systemic disease

- The patient is, in the investigator's opinion, unlikely to comply with the protocol

or is unsuitable for any reason. Other inclusion and exclusion criteria may apply.

Locations and Contacts

US002, Los Angeles, California 90660, United States

US006, San Diego, California 92102, United States

Additional Information

Starting date: February 2013
Last updated: October 28, 2014

Page last updated: August 23, 2015

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