SchizophreniaPhase 4NCT02237417
Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism
A Phase 4 study testing IM aripiprazole once monthly and No Treatment in people with Schizophrenia, run by University of Utah at 1 site in United States.
Trial summary
This is a Phase 4, randomized, open-label, parallel group study designed to assess the clinical and biological effects of 12 months of treatment with long acting intramuscular (IM) aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on magnetic resonance imaging (MRI) scans in subjects… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- IM aripiprazole once monthly and No Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2014to 30 Jul 2020
- Phase
- Phase 4
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are able to provide written informed consent.
- Are male and female subjects 18 to 35 years of age, inclusive, at time of informed consent.
- Have a current diagnosis of schizophrenia as defined by DSM IV-TR criteria and a history of the illness for at least 1 year prior to screening and at least two prior psychotic episodes based on medical records or a qualified and reliable health care provider.
- Require, in the investigator's judgment, chronic treatment with an antipsychotic medication.
- Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot 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 trial screening through 30 days (for females) and 90 days (for males) from the last dose of IMP for SOC oral antipsychotics and 150 days for females and 180 days for males for aripiprazole depot. 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 depot injections, condom, or sponge with spermicide.
Who cannot join
- Presence of any metal implants, pacemakers, unremovable prosthetic device, or other device or situation that may preclude imaging
- History of a head injury with loss of consciousness > 5 minutes
- Has a significant medical condition that would expose the subject to undue risk or interfere with study assessments.
- Has a current DSM-IV-TR 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.
- Is considered resistant/refractory to antipsychotic treatment by history (failed two prior antipsychotic medication trials) or response only to clozapine.
- Has a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's discretion.
Show all 16Show fewer
- Has met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening, excluding caffeine, nicotine, or marijuana.
- Is known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones, or hypersensitivity to antipsychotic agents, including aripiprazole.
- Has a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening per the investigator's discretion.
- 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.
- 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 IM depot or any other antipsychotic depot preparation within 30 days of screening.
- Has clinically significant abnormalities in laboratory test results, vital signs, or ECG results.
- Requires more than one benzodiazepine beyond screening (e.g., lorazepam and oxazepam).
- Fails to washout from prohibited concomitant medications, including the use of or CYP3A4 inducers, a second antipsychotic, antidepressants (including monoamine oxidase inhibitors), and mood stabilizers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Parallel Group, Study of the Impact of Aripiprazole (Abilify®) Once Monthly Versus Standard of Care Oral Antipsychotic Medications on Changes in Brain Structure and Metabolism
This is a Phase 4, randomized, open-label, parallel group study designed to assess the clinical and biological effects of 12 months of treatment with long acting intramuscular (IM) aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral antipsychotic medications and compared with a healthy control group.
Read the detailed description
This is a Phase 4, randomized, open-label, parallel group study designed to assess the clinical and biological effects of 12 months of treatment with long acting intramuscular (IM) aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral antipsychotic medications and compared with a healthy control group.
It is hypothesized that improved treatment compliance will lead to fewer white matter changes in the brain. Fewer white matter changes will be demonstrated via neuroimaging as increased FA and BPF values in the prefrontal region, and an increase in metabolites in a voxel centered on the anterior cingulate cortex (ACC) as seen with MRS. Therefore, the aim of this study is to examine the structural and metabolic effects of aripiprazole (Abilify®) once monthly in patients with schizophrenia using MRI techniques and to examine these effects in association with cognitive and clinical measures.
- Conditions
- Schizophrenia
- Being tested
- Standard of Care Oral antipsychotics, IM aripiprazole once monthly, No Treatment
- Keywords
- MRI, Imaging, Antipsychotic
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Oral antipsychoticsDrug
A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.
IM aripiprazole once monthlyDrug
A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.
No TreatmentOther
A total of 15 healthy controls will participate in the study and will not receive medication
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Other | Healthy individuals with no mental health diagnosis Receives: Other: No Treatment |
| Individuals with Schizophrenia (Group A) | Active comparator | Individuals with a diagnosis of Schizophrenia undergoing standard of care treatments. Receives: Drug: Standard of Care Oral antipsychotics |
| Individuals with Schizophrenia (Group B) | Active comparator | Individuals with Schizophrenia who are receiving treatment with Aripiprazole once monthly injections. Receives: Drug: IM aripiprazole once monthly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Changes in Fractional Anisotropy (FA)
To determine if there are differences in prefrontal white matter fractional anisotropy (FA) in subjects with schizophrenia from baseline at 12 months of treatment with aripiprazole (Abilify®) once monthly compared with standard of care (SOC) oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI (Geodon®)).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study start1 Sep 2014
- Primary completion30 Nov 2018
- Study completion30 Jul 2020
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.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka America Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Deborah Yurgelun-Todd, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237417
- Sponsor's protocol ID
- IRB_00073657
- Status last verified
- Apr 2022
- First submitted
- 3 Sep 2014
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Parallel Group, Study of the Impact of Aripiprazole (Abilify®) Once Monthly Versus Standard of Care Oral Antipsychotic Medications on Changes in Brain Structure and Metabolism
- ClinicalTrials.gov ID
- NCT02237417
- Acronym / sponsor ID
- IRB_00073657
- Conditions
- Schizophrenia
- Keywords
- MRI, Imaging, Antipsychotic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Otsuka America Pharmaceutical
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Posted 15 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, randomized, open-label, parallel group study designed to assess the clinical and biological effects of 12 months of treatment with long acting intramuscular (IM) aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral antipsychotic medications and compared with a healthy control group.
Detailed description
This is a Phase 4, randomized, open-label, parallel group study designed to assess the clinical and biological effects of 12 months of treatment with long acting intramuscular (IM) aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral antipsychotic medications and compared with a healthy control group.
It is hypothesized that improved treatment compliance will lead to fewer white matter changes in the brain. Fewer white matter changes will be demonstrated via neuroimaging as increased FA and BPF values in the prefrontal region, and an increase in metabolites in a voxel centered on the anterior cingulate cortex (ACC) as seen with MRS. Therefore, the aim of this study is to examine the structural and metabolic effects of aripiprazole (Abilify®) once monthly in patients with schizophrenia using MRI techniques and to examine these effects in association with cognitive and clinical measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Other | Other: No TreatmentHealthy individuals with no mental health diagnosis |
| Individuals with Schizophrenia (Group A) | Active comparator | Drug: Standard of Care Oral antipsychoticsIndividuals with a diagnosis of Schizophrenia undergoing standard of care treatments. |
| Individuals with Schizophrenia (Group B) | Active comparator | Drug: IM aripiprazole once monthlyIndividuals with Schizophrenia who are receiving treatment with Aripiprazole once monthly injections. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are able to provide written informed consent.
- Are male and female subjects 18 to 35 years of age, inclusive, at time of informed consent.
- Have a current diagnosis of schizophrenia as defined by DSM IV-TR criteria and a history of the illness for at least 1 year prior to screening and at least two prior psychotic episodes based on medical records or a qualified and reliable health care provider.
- Require, in the investigator's judgment, chronic treatment with an antipsychotic medication.
- Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot 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 (16 listed)
- Presence of any metal implants, pacemakers, unremovable prosthetic device, or other device or situation that may preclude imaging
- History of a head injury with loss of consciousness > 5 minutes
- Has a significant medical condition that would expose the subject to undue risk or interfere with study assessments.
- Has a current DSM-IV-TR 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.
- Is considered resistant/refractory to antipsychotic treatment by history (failed two prior antipsychotic medication trials) or response only to clozapine.
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 |
|---|---|---|
| Standard of Care Oral antipsychoticsA total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling. | Drug | Individuals with Schizophrenia (Group A) |
| IM aripiprazole once monthlyA total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling. | Drug | Individuals with Schizophrenia (Group B) |
| No TreatmentA total of 15 healthy controls will participate in the study and will not receive medication | Other | Healthy Control |
Primary outcome
Number of Participants With Changes in Fractional Anisotropy (FA)
Time frame: 12 months
To determine if there are differences in prefrontal white matter fractional anisotropy (FA) in subjects with schizophrenia from baseline at 12 months of treatment with aripiprazole (Abilify®) once monthly compared with standard of care (SOC) oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI (Geodon®)).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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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.
Deborah Yurgelun-Todd, PhD principal investigator
University of Utah
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 IM aripiprazole once monthly and No Treatment in people with Schizophrenia, run by University of Utah 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 16 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: finished, as of the sponsor's last update on 14 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2021). 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?
Number of Participants With Changes in Fractional Anisotropy (FA) (time frame: 12 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 14 Mar 2025.