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

NCT01795547 | Completed Phase 3 Results

• 2 other identifiers: 14724A2012-002785-12
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score

  The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.

  Baseline, Week 28

Secondary Outcomes (8)

• Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28

  Week 28

• Change From Baseline to Week 28 in CGI-S Score

  Baseline, Week 28

• Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score

  Baseline, Week 28

• Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score

  Baseline, Week 28

• Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score

  Baseline, Week 28

Study Arms (2)

Aripiprazole and aripiprazole once-monthly

EXPERIMENTAL

Drug: Aripiprazole and aripiprazole once-monthly

Paliperidone and paliperidone palmitate

ACTIVE COMPARATOR

Drug: Paliperidone and paliperidone palmitate

Interventions

Aripiprazole and aripiprazole once-monthly DRUG

Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

Also known as: Aripiprazole: Abilify®, Aripiprazole (extended-release injectable suspension): Abilify Maintena®

Aripiprazole and aripiprazole once-monthly

Paliperidone and paliperidone palmitate DRUG

Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

Also known as: Paliperidone: Invega®, Paliperidone palmitate: Xeplion® or Invega® Sustenna®

Paliperidone and paliperidone palmitate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 or has had significant medical condition that would expose him or her to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the study including, but not limited to neurological, hepatic, renal, metabolic, haematological, immunological, gastrointestinal, pulmonary, or cardiovascular disorders.
• The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

US002

Los Angeles, California, 90660, United States

Location

US006

San Diego, California, 92102, United States

Location

Related Publications (2)

• Potkin SG, Loze JY, Forray C, Baker RA, Sapin C, Peters-Strickland T, Beillat M, Nylander AG, Hertel P, Nitschky Schmidt S, Eramo A, Hansen K, Naber D. Multidimensional Assessment of Functional Outcomes in Schizophrenia: Results From QUALIFY, a Head-to-Head Trial of Aripiprazole Once-Monthly and Paliperidone Palmitate. Int J Neuropsychopharmacol. 2017 Jan 1;20(1):40-49. doi: 10.1093/ijnp/pyw093.

  PMID: 27927736 DERIVED

• Naber D, Hansen K, Forray C, Baker RA, Sapin C, Beillat M, Peters-Strickland T, Nylander AG, Hertel P, Andersen HS, Eramo A, Loze JY, Potkin SG. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia. Schizophr Res. 2015 Oct;168(1-2):498-504. doi: 10.1016/j.schres.2015.07.007. Epub 2015 Jul 29.

  PMID: 26232241 DERIVED

Related Links

• EMA EudraCT Results: 2012-002785-12

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole; Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Isoxazoles; Azoles; Pyrimidines

Results Point of Contact

• Title: Study director
• Organization: Email contact via H. Ludbeck A/S

LundbeckClinicalTrials@lundbeck.com

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 17, 2017
• Results First Posted: December 3, 2015

Record last verified: 2017-02

Locations

US (2)