SchizophreniaPhase 4NCT05662306
C-Cog in Early Course Schizophrenia Study
A Phase 4 study testing Aripiprazole Lauroxil and Computerized cognitive and functional skills training in people with Schizophrenia, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole Lauroxil and Computerized cognitive and functional skills training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2024to 3 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Diagnosis of schizophrenia
- Current Hospitalization or outpatient relapse
- Fewer than four previous admissions
- Willing to accept long-acting injectable treatment and participate in rehabilitation
Who cannot join
- Primary diagnosis other than schizophrenia
- Prior Long Acting Injectable treatment
- Current Suicide Risk
- Hypersensitivity to Aripiprazole
- Pregnancy
- Positive illicit drug screen other than cannabis (rescreening allowed in 4 weeks for drug positive cases)
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- Unable to give personal informed consent
- History of treatment resistance as evidenced by clozapine treatment
- Unable to stop treatment with medications that are strong Cytochrome (CYP) 2D6 or CYP 3A4 inhibitors and or strong CYP3A4 inducers (2.3, 7.1) for at 14 days prior to initiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training
The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole Lauroxil, Computerized cognitive and functional skills training
- Keywords
- Relapse, Remission, Recovery
- Medical subject headings
- Schizophrenia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole LauroxilDrug
1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period.
Computerized cognitive and functional skills trainingBehavioural
Self-administered cognitive and technology focused skills training, administered at home for 2 hours per week for the first 12 weeks of the 12-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole and Computerized Cognitive and Functional Skills Training Group | Experimental | Participants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation. Receives: Drug: Aripiprazole Lauroxil; Behavioral: Computerized cognitive and functional skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants Who Develop Sustained Remission of Symptoms of Schizophrenia as Measured as Having a Score of 3 or Less on All 6 Critical Items From the Positive and Negative Syndrome Scale (PANSS)
PANSS has 6 critical items with each item being scored from 1 to 7 with the higher score indicating more severe symptoms. A score of 3 or less on all six critical items defines the presence of remission.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start23 Jan 2024
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Why it stopped: Recruitment issues
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Alkermes, Inc.
- Responsible party
- Principal investigator, Dante Durand, University of Miami
- Investigators
- Dante Durand, MD, Principal investigator, University of Miami Miller School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662306
- Sponsor's protocol ID
- 20211098
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2022
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training
- ClinicalTrials.gov ID
- NCT05662306
- Acronym / sponsor ID
- 20211098
- Conditions
- Schizophrenia
- Keywords
- Relapse, Remission, Recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Alkermes, Inc.
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the role of clinical stability in functional recovery. in first episode schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole and Computerized Cognitive and Functional Skills Training Group | Experimental | Drug: Aripiprazole Lauroxil, Behavioral: Computerized cognitive and functional skills trainingParticipants in this arm will receive long-acting injectable aripiprazole every 2 months formulation for 12 consecutive months. Participants in this arm will also receive Computerized cognitive and functional skills training during the first 12 weeks of study participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults
- Diagnosis of schizophrenia
- Current Hospitalization or outpatient relapse
- Fewer than four previous admissions
- Willing to accept long-acting injectable treatment and participate in rehabilitation
Key exclusion criteria (9 listed)
- Primary diagnosis other than schizophrenia
- Prior Long Acting Injectable treatment
- Current Suicide Risk
- Hypersensitivity to Aripiprazole
- Pregnancy
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 Lauroxil1064 mg 2-month long-acting injectable administered as an intramuscular injection over a 12-month period. | Drug | Aripiprazole and Computerized Cognitive and Functional Skills Training Group |
| Computerized cognitive and functional skills trainingSelf-administered cognitive and technology focused skills training, administered at home for 2 hours per week for the first 12 weeks of the 12-month study period. | Behavioural | Aripiprazole and Computerized Cognitive and Functional Skills Training Group |
Primary outcome
The Percentage of Participants Who Develop Sustained Remission of Symptoms of Schizophrenia as Measured as Having a Score of 3 or Less on All 6 Critical Items From the Positive and Negative Syndrome Scale (PANSS)
Time frame: 6 months
PANSS has 6 critical items with each item being scored from 1 to 7 with the higher score indicating more severe symptoms. A score of 3 or less on all six critical items defines the presence of remission.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dante Durand, MD principal investigator
University of Miami Miller School
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 Lauroxil and Computerized cognitive and functional skills training in people with Schizophrenia, run by University of Miami 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Feb 2026. 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 6 Feb 2026). 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?
The Percentage of Participants Who Develop Sustained Remission of Symptoms of Schizophrenia as Measured as Having a Score of 3 or Less on All 6 Critical Items From the Positive and Negative Syndrome Scale (PANSS) (time frame: 6 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 6 Feb 2026.