SchizophreniaPhase 3NCT01795547
Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
A Phase 3 study testing Aripiprazole and aripiprazole once-monthly and Paliperidone and paliperidone palmitate in people with Schizophrenia, run by H. Lundbeck A/S at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole and aripiprazole once-monthly and Paliperidone and paliperidone palmitate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Sep 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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 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.
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 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
US002
Los Angeles, California, 90660
US006
San Diego, California, 92102
About this study
Official title: A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
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
- Being tested
- Aripiprazole and aripiprazole once-monthly, Paliperidone and paliperidone palmitate
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole and aripiprazole once-monthlyDrug
Also called Aripiprazole: Abilify®, Aripiprazole (extended-release injectable suspension): Abilify Maintena®
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.
Paliperidone and paliperidone palmitateDrug
Also called Paliperidone: Invega®, Paliperidone palmitate: Xeplion® or Invega® Sustenna®
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.
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole and aripiprazole once-monthly | Experimental | Not described Receives: Drug: Aripiprazole and aripiprazole once-monthly |
| Paliperidone and paliperidone palmitate | Active comparator | Not described Receives: Drug: Paliperidone and paliperidone palmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 28
Secondary outcomes (8)
Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28
The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).
Measured: Week 28
Change From Baseline to Week 28 in CGI-S Score
Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Measured: Baseline, Week 28
Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain 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). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning.
Measured: Baseline, Week 28
Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain 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). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning.
Measured: Baseline, Week 28
Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain 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). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.
Measured: Baseline, Week 28
Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain 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). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.
Measured: Baseline, Week 28
Change From Baseline to Week 28 in SWN-S Total Score
The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.
Measured: Baseline, Week 28
Change From Baseline to Week 28 in the TooL Total Score
Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).
Measured: Baseline, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795547
- Sponsor's protocol ID
- 14724A
- Other IDs
- 2012-002785-12
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2013
- Last updated
- 17 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27927736Naber 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.
PubMed 26232241
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01795547
- Acronym / sponsor ID
- 14724A
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Posted 3 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole and aripiprazole once-monthly | Experimental | Drug: Aripiprazole and aripiprazole once-monthly |
| Paliperidone and paliperidone palmitate | Active comparator | Drug: Paliperidone and paliperidone palmitate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole and aripiprazole once-monthlyAlso: Aripiprazole: Abilify®, Aripiprazole (extended-release injectable suspension): Abilify Maintena®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. | Drug | Aripiprazole and aripiprazole once-monthly |
| Paliperidone and paliperidone palmitateAlso: Paliperidone: Invega®, Paliperidone palmitate: Xeplion® or Invega® Sustenna®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. | Drug | Paliperidone and paliperidone palmitate |
Primary outcome
Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
Time frame: Baseline, Week 28
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.
8 secondary outcomes
Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28
Time frame: Week 28
Change From Baseline to Week 28 in CGI-S Score
Time frame: Baseline, Week 28
Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score
Time frame: Baseline, Week 28
Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score
Time frame: Baseline, Week 28
Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score
Time frame: Baseline, Week 28
Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score
Time frame: Baseline, Week 28
Change From Baseline to Week 28 in SWN-S Total Score
Time frame: Baseline, Week 28
Change From Baseline to Week 28 in the TooL Total Score
Time frame: Baseline, Week 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27927736Potkin 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.
- Derived from this study: PubMed 26232241Naber 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.
- EMA EudraCT Results: 2012-002785-12Link provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole and aripiprazole once-monthly and Paliperidone and paliperidone palmitate in people with Schizophrenia, run by H. Lundbeck A/S at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score (time frame: Baseline, Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01795547, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.