SchizophreniaPhase 1NCT01646827

An Open Label Study of Aripiprazole Intramuscular Injection in Subjects With Schizophrenia

A Phase 1 study testing Aripiprazole IM Depot in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 6 sitesUnited States
Study dates: May 2012to Apr 2013
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
Stabilized on oral antipsychotic medication
Good physical health
BMI 18 to 35 kg/m2
Prior history of tolerating aripiprazole

Who cannot join

Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 180 days following the last dose of trial medication, or have not had an orchidectomy or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 150 days following the last dose of trial medication. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide.
Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
Subjects with a positive drug screen for cocaine or other drugs of abuse (excluding stimulants and other prescribed medications and marijuana).
Use of any psychotropic medications other than their current antipsychotic medication.
Use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days (fluoxetine 28 days) prior to dosing and for the duration of the trial.
Females who are pregnant or lactating.

Show all 17Show fewer

Subjects who had participated in a previous IM depot trial within the last one year; or who had previously enrolled and received trial medication in an aripiprazole IM depot clinical trial.
Any major surgery within 30 days prior to enrollment.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical, electrocardiographic, or clinical laboratory examinations.
Subjects who have a significant risk of committing suicide based on history, routine psychiatric status examination, investigator's judgment, or who have an answer of "yes" on questions 4 or 5 (current or over the last 30 days) on the Baseline/Screening version of the Columbia Suicide Severity Rating Scale (C-SSRS).
Subjects currently in an acute relapse of schizophrenia.
Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
Subjects who were considered treatment-resistant to antipsychotic medication.
Subjects who have had electroconvulsive therapy within 2 months of administration of trial drug.
Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
Any other sound medical reason not to be entered into the trial, as determined by the clinical investigator.
Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Community Clinical Research, Inc.
Austin, Texas, 78754
Comprehensive Clinical Development, Inc.
Cerritos, California, 90703
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
CNRI - San Diego
San Diego, California, 92102
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701
Comprehensive Clinical Development, Inc.
Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: An Open-label, Randomized, Parallel Arm, Bioavailability Trial of Aripiprazole IM Depot Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia

The purpose of this study is to determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body

Read the detailed description

Extended-release gluteal intramuscular (IM) injection of aripiprazole has been tested in subjects with schizophrenia for safety and tolerability. This study will compare the gluteal IM aripiprazole injection with deltoid IM aripiprazole injection for safety and tolerability.

Conditions: Schizophrenia
Being tested: Aripiprazole IM Depot
Keywords: Schizophrenia, extended release antipsychotic
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
Also called Abilify
One injection of 400 mg aripiprazole IM depot

Study groups in NCT01646827
Study group	Role	What they receive
Deltoid	Experimental	Deltoid injection site Receives: Drug: Aripiprazole IM Depot
Gluteal	Experimental	Gluteal injection site Receives: Drug: Aripiprazole IM Depot

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Aripriprazole
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Measured: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole
Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters.
Measured: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Measured: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole
Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters.
Measured: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination

Secondary outcomes (8)

Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).
Safety was measured according to standard adverse event collection as described in the adverse event section of the results.
Measured: Starting at the time the ICF was signed to Day 126/Early termination
Number of Participants With Laboratory Values of Potential Clinical Relevance.
The laboratory tests were collected and processed in accordance with directions from the clinical chemistry laboratory. Based on criteria for identifying laboratory values of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For fasting triglycerides: men: ≥ 160 mg/dL and women: ≥ 120 mg/dL; Fasting glucose: ≥ 115 mg/dL; Prolactin: > upper limit of normal (ULN); Neutrophils: ≤ 1,500/mm3; and Creatine phosphokinase: ≥ 3 x ULN.
Measured: Day 1, Day 28, Day 126/Early termination
Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure
Vital sign assessment included orthostatic (supine and standing) blood pressure. Orthostatic assessments were made after participants had been in the supine position for at least 5 minutes and again after participants had been standing for 2 minutes, but not more than 3 minutes. Orthostatic hypotension defined as >/= 20 mm Hg decrease in systolic blood pressure and >/= 25 beats per minute increase in heart rate from supine to standing.
Measured: Day 1, Day 14, Day 28 and Day 126/Early termination
Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature
Vital sign assessment included body temperature measured in centigrade(C). Temperatures >=37.8°C and increase of >= 1.1°C were recorded.
Measured: Day 1, Day 14, Day 28 and Day 126/Early termination
Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate
Vital sign assessment included heart rate (supine and standing). Heart rate with increase or decrease of >/= 15 beats per minute were recorded.
Measured: Day 1, Day 14, Day 28 and Day 126/Early termination
Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance
Three 12 lead ECGs were performed approximately 5 minutes apart at each time point. The participant were supine and at rest (for at least 10 minutes) prior to the first ECG and will remain supine through the final ECG. Based on criteria for identifying ECG measurements of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For bradycardia: ≤ 50 beats per minute (bpm); and for increase in QTc: QTc ≥ 450msec.
Measured: Day 1, Day 14, Day 28 and Day 126/Early termination
Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
Injection site pain was assessed using a VAS, which was completed by the trial participant, and the investigator's assessment of most recent injection site, which was completed by the investigator. VAS is 100 mm line, 0=no pain, 100=unbearably painful.
Measured: Day 1, Day 14, Day 28 and last visit
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit.
Measured: Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Apr 2013

First posted20 Jul 2012 (estimated)
Study startMay 2012
Primary completionApr 2013
Study completionApr 2013

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 (1)Papers the sponsor has linked to this study.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01646827
Sponsor's protocol ID: 31-11-290
Status last verified: Jul 2014
First submitted: 18 Jun 2012
Last updated: 31 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Raoufinia A, Peters-Strickland T, Nylander AG, Baker RA, Eramo A, Jin N, Bricmont P, Repella J, McQuade RD, Hertel P, Larsen F. Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration. Int J Neuropsychopharmacol. 2017 Apr 1;20(4):295-304. doi: 10.1093/ijnp/pyw116.
PubMed 28204607

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Parallel Arm, Bioavailability Trial of Aripiprazole IM Depot Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia
ClinicalTrials.gov ID: NCT01646827
Acronym / sponsor ID: 31-11-290
Conditions: Schizophrenia
Keywords: Schizophrenia, extended release antipsychotic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 20 Jul 2012 (estimated)
Results: Posted 31 Jul 2014

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 determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Deltoid	Experimental	Drug: Aripiprazole IM DepotDeltoid injection site
Gluteal	Experimental	Drug: Aripiprazole IM DepotGluteal injection site

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Diagnosis of schizophrenia
Stabilized on oral antipsychotic medication
Good physical health
BMI 18 to 35 kg/m2
Prior history of tolerating aripiprazole

Key exclusion criteria (17 listed)

Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 180 days following the last dose of trial medication, or have not had an orchidectomy or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 150 days following the last dose of trial medication. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide.
Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
Subjects with a positive drug screen for cocaine or other drugs of abuse (excluding stimulants and other prescribed medications and marijuana).
Use of any psychotropic medications other than their current antipsychotic medication.
Use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days (fluoxetine 28 days) prior to dosing and for the duration of the trial.

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 DepotAlso: AbilifyOne injection of 400 mg aripiprazole IM depot	Drug	Deltoid, Gluteal

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Aripriprazole
Time frame: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole
Time frame: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters.
Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole
Time frame: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole
Time frame: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters.

8 secondary outcomes

Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).
Time frame: Starting at the time the ICF was signed to Day 126/Early termination
Number of Participants With Laboratory Values of Potential Clinical Relevance.
Time frame: Day 1, Day 28, Day 126/Early termination
Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure
Time frame: Day 1, Day 14, Day 28 and Day 126/Early termination
Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature
Time frame: Day 1, Day 14, Day 28 and Day 126/Early termination
Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate
Time frame: Day 1, Day 14, Day 28 and Day 126/Early termination
Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance
Time frame: Day 1, Day 14, Day 28 and Day 126/Early termination
Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
Time frame: Day 1, Day 14, Day 28 and last visit
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Time frame: Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.

Results and safety

Results posted to the registry on 31 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole IM Depot 400 mg: Deltoid	18	16
Aripiprazole IM Depot 400 mg: Gluteal	19	14

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Aripriprazole

Time frame: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination. Mean (Standard Deviation). Unit: ng/mL

Measure	Aripiprazole IM Depot 400 mg: Deltoid n = 16	Aripiprazole IM Depot 400 mg: Gluteal n = 17
Value	170 (58.6)	136 (70.3)

Population analysed: The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.

Primary outcome: Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole

Measure	Aripiprazole IM Depot 400 mg: Deltoid n = 16	Aripiprazole IM Depot 400 mg: Gluteal n = 17
AUC infinity (n=16,14)	7590 (2590)	7920 (2580)
AUC 28 (n=16,17)	3120 (1150)	2380 (1410)
AUC t (n=16,17)	7360 (2420)	7340 (2360)

Population analysed: The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole

Measure	Aripiprazole IM Depot 400 mg: Deltoid n = 16	Aripiprazole IM Depot 400 mg: Gluteal n = 17
Value	51.7 (23.3)	34.6 (13.2)

Population analysed: The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.

Primary outcome: Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole

Measure	Aripiprazole IM Depot 400 mg: Deltoid n = 16	Aripiprazole IM Depot 400 mg: Gluteal n = 17
AUC infinity (n=16,14)	2520 (836)	2230 (630)
AUC 28 (n=16,17)	886 (445)	538 (305)
AUC t (n=16,17)	2420 (805)	1990 (603)

Population analysed: The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole IM Depot 400 mg: Deltoid	0 of 17 (0%)	14 of 17 (82.4%)	Not reported
Aripiprazole IM Depot 400 mg: Gluteal	0 of 18 (0%)	18 of 18 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28204607Raoufinia A, Peters-Strickland T, Nylander AG, Baker RA, Eramo A, Jin N, Bricmont P, Repella J, McQuade RD, Hertel P, Larsen F. Aripiprazole Once-Monthly 400 mg: Comparison of Pharmacokinetics, Tolerability, and Safety of Deltoid Versus Gluteal Administration. Int J Neuropsychopharmacol. 2017 Apr 1;20(4):295-304. doi: 10.1093/ijnp/pyw116.

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.

Timothy Peters-Strickland, MD study director

Otsuka Pharmaceutical Development & Commercialization, Inc.

6 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 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 6 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 5 inclusion and 17 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 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 31 Jul 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?

Maximum Observed Plasma Concentration (Cmax) of Aripriprazole (time frame: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination). 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?

On the ClinicalTrials.gov record for NCT01646827, which also lists 1 linked publication.

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 31 Jul 2014.