SchizophreniaPhase 1NCT01870999
A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
A Phase 1 study testing aripiprazole IM depot and aripiprazole tablets in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 7 sites in United States.
Trial summary
This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- aripiprazole IM depot and aripiprazole tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2007to Oct 2008
- Phase
- Phase 1
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
- good physical health as determined by normal medical history, clinical laboratory results, electrocardiograms (ECGs) and physical examinations
- ability to provide informed consent and/or consent from a legally acceptable representation
- body mass index (BMI) of 18 to 35 kg/m^2
Who cannot join
- sexually active males and females of child-bearing potential who are not practicing double barrier birth control or are not abstinent during the study plus 30 days for female or 90 days for males following the last dose of medication
- history of drug or alcohol abuse within 6 months and/or positive urine drug screen
- participants who consume alcohol beverages routinely
- participants who consume alcohol beverages during the screening period
- use of any antipsychotic medication, other prohibited psychotropic medication, and any cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 inducers within 14 days
- use of any prescription medication unless approved by Medical Monitor or Study Director
Show all 19Show fewer
- history of current hepatitis or carrier of HBsAg (Hepatitis B surface antigen) and/or Hepatitis C Virus antibodies (anti-HCV)
- females who are pregnant or lactating
- participants who have participated in any clinical trial involving a psychotropic medication within one month prior to enrollment; participants who have participated in a previous IM Depot study within the last 1 year; patients who have previously enrolled and received study medication in an aripiprazole IM Depot clinical trial
- donation of blood or plasma to a blood bank or in a clinical study (except a screening visit)within 30 days prior to enrollment
- any major surgery within 30 days prior to enrollment
- blood transfusion within 30 days prior to enrollment
- evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations
- patient represents a significant risk of committing suicide based on history
- patients currently in an acute relapse
- patients with Axis I (DSM-IV) diagnosis of schizoaffective or bipolar disorder
- patients who are considered treatment-resistant to antipsychotic medication
- patients with a history of neuroleptic malignant syndrome
- any other sound medical reason as determined by the clinical investigator
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Otsuka Investigative Site
Austin, Texas, 78756
Otsuka Investigative Site
Cerritos, California, 90703
Otsuka Investigative Site
Garden Grove, California, 92845
Otsuka Investigative Site
Glendale, California, 91206
Otsuka Investigative Site
Paramount, California, 90723
Otsuka Investigative Site
St Louis, Missouri, 63118
Otsuka Investigative Site
Willingboro, New Jersey, 08046
About this study
Official title: An Open-label Parallel Arm Multiple Dose Tolerability, Pharmacokinetics and Safety Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot Formulation Once Every Four Weeks
This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- aripiprazole IM depot, aripiprazole tablets
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazole IM depotDrug
Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.
aripiprazole tabletsDrug
Aripiprazole tablets 10 mg once daily in the morning for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 400 mg Aripiprazole IM Depot | Experimental | 400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. Receives: Drug: aripiprazole IM depot; Drug: aripiprazole tablets |
| 300 mg Aripiprazole IM Depot | Experimental | 300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. Receives: Drug: aripiprazole IM depot; Drug: aripiprazole tablets |
| 200 mg Aripiprazole IM depot | Experimental | 200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. Receives: Drug: aripiprazole IM depot; Drug: aripiprazole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety
Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.
Measured: 7 Months
Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection.
Measured: 672 hours post-dose at Month 5
Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Secondary outcomes (13)
Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Aripiprazole Steady-state Plasma Concentration (Css,Avg)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,avg were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for t1/2,z were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,min were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Measured: Pre-dose and 1 to 1344 hours post-dose at Month 5
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24
The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.
Measured: Baseline, Week 12, Week 24
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24
The PANSS Positive Subscale consisted of 7 symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.
Measured: Baseline, Week 12, Week 24
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24
The PANSS Negative Subscale consisted of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12, Week 24
Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24
The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement.
Measured: Baseline, Week 12, Week 24
Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24
The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
Measured: Baseline, Week 12, Week 24
Number of Participants Hospitalized for Adverse Event "Worsening Schizophrenia"
The number of participants hospitalized for the Adverse Event "Worsening Schizophrenia included all participants who were hospitalized for any Adverse Event pertaining to the exacerbation of schizophrenic symptoms.
Measured: 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
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 Otsuka Pharmaceutical Development & Commercialization, Inc.The 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870999
- Sponsor's protocol ID
- 31-05-244
- Status last verified
- Dec 2013
- First submitted
- 4 Jun 2013
- Last updated
- 22 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Parallel Arm Multiple Dose Tolerability, Pharmacokinetics and Safety Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot Formulation Once Every Four Weeks
- ClinicalTrials.gov ID
- NCT01870999
- Acronym / sponsor ID
- 31-05-244
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 22 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 400 mg Aripiprazole IM Depot | Experimental | Drug: aripiprazole IM depot, Drug: aripiprazole tablets400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. |
| 300 mg Aripiprazole IM Depot | Experimental | Drug: aripiprazole IM depot, Drug: aripiprazole tablets300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. |
| 200 mg Aripiprazole IM depot | Experimental | Drug: aripiprazole IM depot, Drug: aripiprazole tablets200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
- good physical health as determined by normal medical history, clinical laboratory results, electrocardiograms (ECGs) and physical examinations
- ability to provide informed consent and/or consent from a legally acceptable representation
- body mass index (BMI) of 18 to 35 kg/m^2
Key exclusion criteria (19 listed)
- sexually active males and females of child-bearing potential who are not practicing double barrier birth control or are not abstinent during the study plus 30 days for female or 90 days for males following the last dose of medication
- history of drug or alcohol abuse within 6 months and/or positive urine drug screen
- participants who consume alcohol beverages routinely
- participants who consume alcohol beverages during the screening period
- use of any antipsychotic medication, other prohibited psychotropic medication, and any cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 inducers within 14 days
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 IM depotAripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection. | Drug | 200 mg Aripiprazole IM depot, 300 mg Aripiprazole IM Depot, 400 mg Aripiprazole IM Depot |
| aripiprazole tabletsAripiprazole tablets 10 mg once daily in the morning for 14 days. | Drug | 200 mg Aripiprazole IM depot, 300 mg Aripiprazole IM Depot, 400 mg Aripiprazole IM Depot |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety
Time frame: 7 Months
Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.
Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.
Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
Time frame: 672 hours post-dose at Month 5
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection.
Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.
13 secondary outcomes
Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Aripiprazole Steady-state Plasma Concentration (Css,Avg)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
Time frame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24
Time frame: Baseline, Week 12, Week 24
Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24
Time frame: Baseline, Week 12, Week 24
Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24
Time frame: Baseline, Week 12, Week 24
Number of Participants Hospitalized for Adverse Event "Worsening Schizophrenia"
Time frame: 7 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aripiprazole IM depot and aripiprazole tablets in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 7 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?
The sponsor lists 4 inclusion and 19 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 22 Jan 2014). 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 Adverse Events as a Measure of Safety (time frame: 7 Months). The study lists 4 primary outcomes in all. 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 22 Jan 2014.