SchizophreniaPhase 4NCT02282085
Treatment Study Comparing Aripiprazole Once Monthly With Standard of Care Medication in Outpatients With Schizophrenia
A Phase 4 study testing Aripiprazole Once-Monthly and Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc) in people with Schizophrenia, run by Matt Byerly at 1 site in United States.
Trial summary
This study compares aripiprazole once-monthly injection to standard of care oral antipsychotic medication in non-adherent outpatients with schizophrenia to see which treatment helps people take their medicine more regularly and have more positive outcomes. 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 Once-Monthly and Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- Are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to the initiation of any protocol-required procedure.
- Are 18 to 60 years of age, inclusive, at the time of informed consent
- Has a current diagnosis of schizophrenia, as defined by DSM-V criteria and a history of the illness for at least 6 months prior to screening from a reliable source (e.g., health care provider, family member, or medical records).
- Have been prescribed a single oral antipsychotic medication for at least 3 months prior to screening.
- Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, intramuscular (IM) once monthly injection, and discontinuation of prohibited concomitant medications, read and understand the written word in order to complete subject-reported outcomes measures, and be reliably rated on assessment scales.
- Are male and female subjects who are surgically sterile (i.e., have undergone orchiectomy or hysterectomy, respectively; female subjects who have been postmenopausal for at least 12 consecutive months; or male and female subjects who agree to remain abstinent or to practice double barrier forms of birth control from study screening through 30 days (for females) and 90 days (for males) from the last dose of study drug for SOC oral antipsychotics and 150 days for females and 180 days for males for aripiprazole once monthly. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, birth control once monthly injections, condom, or sponge with spermicide.
Who cannot join
- Has a current DSM-V diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also excluded are subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- Has had a psychiatric hospitalization within the 30 days prior to screening.
- Has received a depot antipsychotic within the 6 months prior to screening.
- Is considered resistant or refractory to antipsychotic treatment by history (failed two prior antipsychotic medication studies) or response only to clozapine.
- Is taking two or more antipsychotics.
- Has a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's discretion.
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- Has a history of seizures or any other medical condition that would expose the subject to undue risk or interfere with study assessments.
- Is involuntarily incarcerated or has been incarcerated in the past 6 months for any reason.
- Has undergone electroconvulsive therapy in the 2 years prior to enrollment in the study.
- Has used an investigational agent or has participated in a clinical study with aripiprazole once monthly or any other antipsychotic once monthly preparation within 30 days of screening.
- Has any medical condition that might preclude safe completion of the study (e.g., agranulocytosis, severe and unstable heart disease, AIDS, end-stage renal disease).
- Is taking a CYP3A4 inducer (e.g., carbamazepine).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Matt Byerly, MD
About this study
Official title: A Randomized, Multi-site, Parallel-group, Rater-blind Study Comparing Response With Aripiprazole Once Monthly and Standard of Care Oral Antipsychotics in Non-adherent Outpatients With Schizophrenia Identified Using the Brief Adherence Rating Scale
This study compares aripiprazole once-monthly injection to standard of care oral antipsychotic medication in non-adherent outpatients with schizophrenia to see which treatment helps people take their medicine more regularly and have more positive outcomes.
It is hypothesized that non-adherent schizophrenia outpatients receiving aripiprazole once-monthly will be more likely to respond and have lower symptom severity over 3 months of treatment than those receiving standard of care oral antipsychotics.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole Once-Monthly, Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)
- Keywords
- Medication Non-Adherence, Antipsychotic
- Medical subject headings
- Schizophrenia, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole Once-MonthlyDrug
Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)Drug
Oral antipsychotic medication
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole Once-Monthly | Experimental | Switch to 400 mg aripiprazole once-monthly injection Receives: Drug: Aripiprazole Once-Monthly |
| Standard of Care | Active comparator | Continue current SOC oral antipsychotic medication Receives: Drug: Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: PANSS (Positive and Negative Syndrome Scale) total score improvement - response
PANSS total score - operationalized as a binary response, defined as at least a 20% improvement in PANSS totals core, from the three monthly visits.
Measured: from date of randomization up to 3 months
Secondary outcomes (5)
Efficacy: PANSS total score overall - symptom severity
PANSS total score - continuous, from the three monthly visits
Measured: from date of randomization up to 3 months
Quality of Life
Schizophrenia Quality of Life Scale (SQLS)
Measured: from date of randomization up to 3 months
Cognition
Brief Assessment of Cognition in Schizophrenia (BACS)
Measured: from date of randomizatino up to 3 months
Substance Use
Alcohol Use Scale (AUS) and Drug Use Scale (DUS)
Measured: from date of randomization up to 3 months
Safety assessed by Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: from date of randomization up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matt Byerly
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka America Pharmaceutical
- Responsible party
- Sponsor-investigator, Matt Byerly, University of Texas Southwestern Medical Center
- Investigators
- Matt Byerly, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282085
- Sponsor's protocol ID
- COL.AOM.2013.004
- Status last verified
- Jun 2015
- First submitted
- 30 Sep 2014
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-site, Parallel-group, Rater-blind Study Comparing Response With Aripiprazole Once Monthly and Standard of Care Oral Antipsychotics in Non-adherent Outpatients With Schizophrenia Identified Using the Brief Adherence Rating Scale
- ClinicalTrials.gov ID
- NCT02282085
- Acronym / sponsor ID
- COL.AOM.2013.004
- Conditions
- Schizophrenia
- Keywords
- Medication Non-Adherence, Antipsychotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Matt ByerlyUniversity, hospital or other
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares aripiprazole once-monthly injection to standard of care oral antipsychotic medication in non-adherent outpatients with schizophrenia to see which treatment helps people take their medicine more regularly and have more positive outcomes.
It is hypothesized that non-adherent schizophrenia outpatients receiving aripiprazole once-monthly will be more likely to respond and have lower symptom severity over 3 months of treatment than those receiving standard of care oral antipsychotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole Once-Monthly | Experimental | Drug: Aripiprazole Once-MonthlySwitch to 400 mg aripiprazole once-monthly injection |
| Standard of Care | Active comparator | Drug: Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)Continue current SOC oral antipsychotic medication |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to the initiation of any protocol-required procedure.
- Are 18 to 60 years of age, inclusive, at the time of informed consent
- Has a current diagnosis of schizophrenia, as defined by DSM-V criteria and a history of the illness for at least 6 months prior to screening from a reliable source (e.g., health care provider, family member, or medical records).
- Have been prescribed a single oral antipsychotic medication for at least 3 months prior to screening.
- Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, intramuscular (IM) once monthly injection, and discontinuation of prohibited concomitant medications, read and understand the written word in order to complete subject-reported outcomes measures, and be reliably rated on assessment scales.
Key exclusion criteria (12 listed)
- Has a current DSM-V diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also excluded are subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- Has had a psychiatric hospitalization within the 30 days prior to screening.
- Has received a depot antipsychotic within the 6 months prior to screening.
- Is considered resistant or refractory to antipsychotic treatment by history (failed two prior antipsychotic medication studies) or response only to clozapine.
- Is taking two or more antipsychotics.
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 Once-Monthly | Drug | Aripiprazole Once-Monthly |
| Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)Oral antipsychotic medication | Drug | Standard of Care |
Primary outcome
Efficacy: PANSS (Positive and Negative Syndrome Scale) total score improvement - response
Time frame: from date of randomization up to 3 months
PANSS total score - operationalized as a binary response, defined as at least a 20% improvement in PANSS totals core, from the three monthly visits.
5 secondary outcomes
Efficacy: PANSS total score overall - symptom severity
Time frame: from date of randomization up to 3 months
Quality of Life
Time frame: from date of randomization up to 3 months
Cognition
Time frame: from date of randomizatino up to 3 months
Substance Use
Time frame: from date of randomization up to 3 months
Safety assessed by Treatment-emergent adverse events (TEAEs), physical examination including vital signs, clinical laboratory testing including prolactin and lipid profiles, and the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: from date of randomization up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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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.
Matt Byerly, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole Once-Monthly and Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc) in people with Schizophrenia, run by Matt Byerly at 1 site 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?
The sponsor lists 6 inclusion and 12 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Bannister (214-648-4603, elizabeth.bannister@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: PANSS (Positive and Negative Syndrome Scale) total score improvement - response (time frame: from date of randomization up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2015.