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Trial record 32 of 405 for:    ARIPIPRAZOLE

A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03854409
Recruitment Status : Active, not recruiting
First Posted : February 26, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
PRA Health Sciences
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar I disorder.

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar I Disorder Drug: Aripiprazole Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Single- and Multiple-dose, Pharmacokinetic, Safety, and Tolerability Trial of Aripiprazole Long-acting Injectable Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder
Actual Study Start Date : January 31, 2019
Actual Primary Completion Date : April 5, 2019
Estimated Study Completion Date : September 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Deltoid Site: Single Dose Group
Participants will receive a single dose of aripiprazole LAI.
Drug: Aripiprazole
Injection.
Other Name: (OPC-14597)

Experimental: Gluteal Site: Single Dose Group
Participants will receive a single dose of aripiprazole LAI.
Drug: Aripiprazole
Injection.
Other Name: (OPC-14597)

Experimental: Deltoid Site: Multiple Dose Group
Participants will receive five injections of aripiprazole LAI, administered at monthly intervals.
Drug: Aripiprazole
Injection.
Other Name: (OPC-14597)

Experimental: Gluteal Site: Multiple Dose Group
Participants will receive five injections of aripiprazole LAI, administered at monthly intervals.
Drug: Aripiprazole
Injection.
Other Name: (OPC-14597)




Primary Outcome Measures :
  1. Single Dose Group: Maximum Observed Plasma Concentration (Cmax) for Aripiprazole [ Time Frame: Day 1 to Day 126 ]
  2. Single Dose Group: Maximum Observed Plasma Concentration (Cmax) for Dehydro-Aripiprazole [ Time Frame: Day 1 to Day 126 ]
  3. Single Dose Group: Plasma Concentration of the Drug at 28 Days Postdose (C28) for Aripiprazole [ Time Frame: Day 28 ]
  4. Single Dose Group: Plasma Concentration of the Drug at 28 Days Postdose (C28) for Dehydro-Aripiprazole [ Time Frame: Day 28 ]
  5. Single Dose Group: Time to Reach the Maximum Plasma Concentration for Aripiprazole (Tmax) [ Time Frame: Day 1 to Day 126 ]
  6. Single Dose Group: Time to Reach the Maximum Plasma Concentration for Dehydro-Aripiprazole (Tmax) [ Time Frame: Day 1 to Day 126 ]
  7. Single Dose Group: Area Under the Concentration-Time Curve from time Zero to Time t (the Last Observable Concentration; AUCt) for Aripiprazole [ Time Frame: Day 1 to Day 126 ]
  8. Single Dose Group: Area Under the Concentration-Time Curve from time Zero to Time t (the Last Observable Concentration; AUCt) for Dehydro-Aripiprazole [ Time Frame: Day 1 to Day 126 ]
  9. Single Dose Group: Area Under the Concentration-Time Curve from Time Zero to 28 Days Postdose (AUC0-28) for Aripiprazole [ Time Frame: Day 1 to Day 28 ]
  10. Single Dose Group: Area Under the Concentration-Time Curve from Time Zero to 28 Days Postdose (AUC0-28) for Dehydro-Aripiprazole [ Time Frame: Day 1 to Day 28 ]
  11. Single Dose Group: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Aripiprazole (AUC∞) for Aripiprazole [ Time Frame: Day 1 to Day 126 ]
  12. Single Dose Group: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Aripiprazole (AUC∞) for Dehydro-Aripiprazole [ Time Frame: Day 1 to Day 126 ]
  13. Single Dose Group: Terminal Phase Elimination Half-life (T1/2) for Aripiprazole [ Time Frame: Day 1 to Day 126 ]
  14. Single Dose Group: Terminal Phase Elimination Half-life (T1/2) for Dehydro-Aripiprazole [ Time Frame: Day 1 to Day 126 ]
  15. Single Dose Group: Oral Clearance (CL/F) for Aripiprazole Only [ Time Frame: Day 1 to Day 126 ]
    Apparent clearance of the drug from plasma after extravascular administration (CL/F)

  16. Multiple Dose Group: Cmax for Aripiprazole (Following the Fifth Dose Only) [ Time Frame: Day 113 to Day 169 ]
    Fifth dose will be administered on Day 113.

  17. Multiple Dose Group: Cmax for Dehydro-Aripiprazole (Following the Fifth Dose Only) [ Time Frame: Day 113 to Day 169 ]
    Fifth dose will be administered on Day 113.

  18. Multiple Dose Group: Plasma Concentration of the Drug at 28 Days Postdose (C28) for Aripiprazole [ Time Frame: Day 29, Day 57, Day 84, Day 113, Day 141 (All post-dose) ]
  19. Multiple Dose Group: Plasma Concentration of the Drug at 28 Days Postdose (C28) for Dehydro-Aripiprazole [ Time Frame: Day 29, Day 57, Day 84, Day 113, Day 141 (All post-dose) ]
  20. Multiple Dose Group: tmax (Following the Fifth Dose Only) for Aripiprazole [ Time Frame: Day 113 to Day 169 ]
    Participants will receive their 5th dose on Day 113.

  21. Multiple Dose Group: tmax (Following the Fifth Dose Only) for Dehydro-Aripiprazole [ Time Frame: Day 113 to Day 169 ]
    Participants will receive their 5th dose on Day 113.

  22. Multiple Dose Group: AUC0-28 (Following the Fifth Dose Only) for Aripiprazole [ Time Frame: Day 113 to Day 169 ]
    Participants will receive their 5th dose on Day 113.

  23. Multiple Dose Group: AUC0-28 (Following the Fifth Dose Only) for Dehydro-Aripiprazole [ Time Frame: Day 113 to Day 169 ]
    Participants will receive their 5th dose on Day 113.

  24. Multiple Dose Group: t1/2 (Following the Fifth Dose Only) for Aripiprazole [ Time Frame: Day 113 to Day 169 ]
    Participants will receive their 5th dose on Day 113.

  25. Multiple Dose Group: t1/2 (Following the Fifth Dose Only) for Deydro-Aripiprazole [ Time Frame: Day 113 to Day 169 ]
    Participants will receive their 5th dose on Day 113.

  26. Multiple Dose Group: CL/F (Following the Fifth Dose Only; for Aripiprazole Only) [ Time Frame: Day 113 to Day 169 ]
    Participants will receive their 5th dose on Day 113.

  27. Multiple Dose Group: Ratio of Dehydro-Aripiprazole to Aripiprazole C28 and AUC0-28 (Following the Fifth Dose Only) [ Time Frame: Day 113 (following fifth dose) to Day 141 ]
    Participants will receive their 5th dose on Day 113.


Secondary Outcome Measures :
  1. Single Dose: Number of Participants with an Adverse Event (AE) [ Time Frame: Day 1 to End of Trial (Maximum 126 Days from First Dose) ]
    An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  2. Multiple Dose: Number of Participants with an Adverse Event (AE) [ Time Frame: Day 1 to End of Trial (Maximum 169 Days from First Dose) ]
    An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

  3. Single Dose: Number of Participants with Markedly Abnormal Vital Sign Measurements [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    Vital signs will be obtained prior to PK blood draws. Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.

  4. Multiple Dose: Number of Participants with Markedly Abnormal Vital Sign Measurements [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    Vital signs will be obtained prior to PK blood draws. Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.

  5. Single Dose: Number of Participants with Markedly Abnormal Electrocardiograms (ECGs) Results [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    Standard 12-lead ECGs will be collected in triplicate (5 minutes apart). The ECGs will be collected prior to PK blood draws and after vital signs at the nominal time points, where applicable.

  6. Multiple Dose: Number of Participants with Markedly Abnormal Electrocardiograms (ECGs) Results [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    Standard 12-lead ECGs will be collected in triplicate (5 minutes apart). The ECGs will be collected prior to PK blood draws and after vital signs at the nominal time points, where applicable.

  7. Single Dose: Number of Participants with Markedly Abnormal Clinical Laboratory Results [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    Clinical Laboratory Monitoring includes serum chemistry, hematology and urinalysis.

  8. Multiple Dose: Number of Participants with Markedly Abnormal Clinical Laboratory Results [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    Clinical Laboratory Monitoring includes serum chemistry, hematology and urinalysis.

  9. Single Dose: Change from Baseline in Serum Prolactin [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
  10. Multiple Dose: Change from Baseline in Serum Prolactin [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
  11. Single Dose: Number of Participants with Markedly Abnormal Physical Examination Results [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
  12. Multiple Dose: Number of Participants with Markedly Abnormal Physical Examination Results [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
  13. Single Dose: Visual Analog Scale (VAS) Scores for Injection Site Pain Perception [ Time Frame: Day 1 immediately post-dose, 1 hour post-dose (+/- 15 minutes), Day 14 and Day 29 ]
    VAS scores at Day 1 immediately post-dose, 1 hour post-dose (+/- 15 minutes), Day 14 and Day 29. The VAS is a test to assess injection site pain. Participants will be asked to give a score between 0-10 to rate pain, with 0 being no pain and 10 being worst possible pain.

  14. Multiple Dose: Visual Analog Scale (VAS) Scores for Injection Site Pain Perception [ Time Frame: 1-hour post-dose Day 1, Day 29, Day 57, Day 85, Day 113 ]
    VAS scores at 1-hour post-dose on Day 1, Day 29, Day 57, Day 85, Day 113. The VAS is a test to assess injection site pain. Participants will be asked to give a score between 0-10 to rate pain, with 0 being no pain and 10 being worst possible pain.

  15. Single Dose: Change from Baseline of Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    Suicidality will be monitored throughout the trial using the C-SSRS (Columbia-Suicide Severity Rating Scale). This scale consists of a baseline evaluation that assesses the lifetime experience of the subject with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last assessment.The Baseline/Screening Version and the Since Last Visit version of the C-SSRS will be completed by trained trial site staff at each visit. A numerical score will correspond to one of ten categories relating to suicidal ideation and suicidal behavior. A higher score indicates a higher risk of suicidal behavior, but an answer of 'yes' to any question indicates some risk.

  16. Multiple Dose: Change from Baseline of Columbia-Suicide Severity Rating Scale (C-SSRS) Score [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    Suicidality will be monitored throughout the trial using the C-SSRS (Columbia-Suicide Severity Rating Scale). This scale consists of a baseline evaluation that assesses the lifetime experience of the subject with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last assessment.The Baseline/Screening Version and the Since Last Visit version of the C-SSRS will be completed by trained trial site staff at each visit. A numerical score will correspond to one of ten categories relating to suicidal ideation and suicidal behavior. A higher score indicates a higher risk of suicidal behavior, but an answer of 'yes' to any question indicates some risk.

  17. Single Dose: Number of Injection Site Related Adverse Events [ Time Frame: End of Trial (Maximum 126 Days from First Dose) ]
    An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.The injection site will be monitored by the investigator to assess the safety and tolerability of the drug.

  18. Multiple Dose: Number of Injection Site Related Adverse Events [ Time Frame: End of Trial (Maximum 169 Days from First Dose) ]
    An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.The injection site will be monitored by the investigator to assess the safety and tolerability of the drug.

  19. Single Dose: Change from Baseline in Assessment of Extrapyramidal Symptoms (EPS) [ Time Frame: Day 1 (predose) to End of Trial (Maximum 126 Days from First Dose) ]
    EPS will be assessed using Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Rating Scale (BARS). The SAS consists of a list of 10 symptoms of Parkinsonism. Each item will be rated on a 5-point scale, with a score of 1 representing absence of symptoms and a score of 5 representing a severe condition. The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item will be rated on a 5-point scale, with a score of 0 representing absence of symptoms, and a score of 4 indicating a severe condition. The BARS consist of 4 items related to akathisia. The first 3 items will be rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation will be made on a 6-point scale, with 0 representing absence of symptoms and 5 representing severe akathisia.

  20. Multiple Dose: Change from Baseline in Assessment of Extrapyramidal Symptoms (EPS) [ Time Frame: Day 1 (predose) to End of Trial (Maximum 169 Days from First Dose) ]
    EPS will be assessed using Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Rating Scale (BARS). The SAS consists of a list of 10 symptoms of Parkinsonism. Each item will be rated on a 5-point scale, with a score of 1 representing absence of symptoms and a score of 5 representing a severe condition. The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item will be rated on a 5-point scale, with a score of 0 representing absence of symptoms, and a score of 4 indicating a severe condition. The BARS consist of 4 items related to akathisia. The first 3 items will be rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation will be made on a 6-point scale, with 0 representing absence of symptoms and 5 representing severe akathisia.

  21. Single Dose: Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Score [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    The PANSS will be administered using the Structured Clinical Interview-PANSS. The PANSS consists of 3 subscales containing a total of 30 symptom constructs.13 For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. This analysis will include participants with schizophrenia only.

  22. Multiple Dose: Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Score [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    The PANSS will be administered using the Structured Clinical Interview-PANSS. The PANSS consists of 3 subscales containing a total of 30 symptom constructs.13 For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. This analysis will include participants with schizophrenia only.

  23. Single Dose: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    The CGI-S Scale will be used to rate the severity of illness for each participant. The scale is a 7-point likert scale, where 1 indicates no illness and 7 indicates extremely ill.

  24. Multiple Dose: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    The CGI-S Scale will be used to rate the severity of illness for each participant. The scale is a 7-point likert scale, where 1 indicates no illness and 7 indicates extremely ill.

  25. Single Dose: Change from Baseline in Subjective Well-being under Neuroleptic Treatment-Short Form (SWN-S) Score [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    The subject's feeling of their own well-being will be assessed using the 20 question SWN-S. The questionnaire consists of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items follow in random order. For items marked with a '+', response choices and scoring are as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1.

  26. Multiple Dose: Change from Baseline in Subjective Well-being under Neuroleptic Treatment-Short Form (SWN-S) Score [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    The subject's feeling of their own well-being will be assessed using the 20 question SWN-S. The questionnaire consists of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items follow in random order. For items marked with a '+', response choices and scoring are as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1.

  27. Single Dose: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    The MADRS will be utilized as the primary assessment of a subject's level of depressive symptoms and must be administered using a structured interview guide. This scale consists of 10 items each with 7 defined grades of severity.This analysis will include participants with bipolar only.

  28. Multiple Dose: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    The MADRS will be utilized as the primary assessment of a subject's level of depressive symptoms and must be administered using a structured interview guide. This scale consists of 10 items each with 7 defined grades of severity.This analysis will include participants with bipolar only.

  29. Single Dose: Change from Baseline in Young Mania Rating Scale (YMRS) Score [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    The YMRS consists of 11 items assessing the core symptoms of mania and is based on the subject's subjective report of his or her clinical condition. Each item has 5 defined categories of severity with 4 items graded on a 0 to 8 scale (irritability, speech, content, and disruptive-aggressive behavior) and 7 items graded on a 0 to 4 scale. This analysis will include participants with bipolar only.

  30. Multiple Dose: Change from Baseline in Young Mania Rating Scale (YMRS) Score [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    The YMRS consists of 11 items assessing the core symptoms of mania and is based on the subject's subjective report of his or her clinical condition. Each item has 5 defined categories of severity with 4 items graded on a 0 to 8 scale (irritability, speech, content, and disruptive-aggressive behavior) and 7 items graded on a 0 to 4 scale. This analysis will include participants with bipolar only.

  31. Single Dose: Change from Baseline in Clinical Global Impression-Bipolar Version (CGI-BP) Score [ Time Frame: Baseline to End of Trial (Maximum 126 Days from First Dose) ]
    Severity of illness will be measured using the CGI-BP score. To assess CGI-S, the investigator will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the subject at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. This analysis will include participants with bipolar only.

  32. Multiple Dose: Change from Baseline in Clinical Global Impression-Bipolar Version (CGI-BP) Score [ Time Frame: Baseline to End of Trial (Maximum 169 Days from First Dose) ]
    Severity of illness will be measured using the CGI-BP score. To assess CGI-S, the investigator will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the subject at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. This analysis will include participants with bipolar only.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects between 18 and 64 years of age, inclusive.
  • Body mass index of 18 to 35 kg/m2, inclusive.
  • A current diagnosis of schizophrenia or a current diagnosis of bipolar I disorder as defined by DSM-5 criteria.
  • Prior history of tolerating aripiprazole per investigator's judgment.

Exclusion Criteria:

  • Subjects who have met DSM-5 criteria for substance dependence within the past 180 days
  • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening.
  • Subjects may not receive varenicline beyond screening.
  • Use of any prescription medication not specifically approved by the medical monitor.
  • Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female subjects.
  • Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous aripiprazole LAI trial within the last 1 year (ie, enrolled but did not receive aripiprazole LAI); or who had previously enrolled and received IMP in an aripiprazole LAI clinical trial.
  • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
  • Subjects currently in an acute relapse of schizophrenia.
  • Subjects with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder
  • Electroconvulsive therapy must not be conducted within 2 months prior to administration of the IMP
  • Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies.
  • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
  • Subjects deemed intolerant of receiving injections.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854409


Locations
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United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
United States, California
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
United States, Texas
Community Clinical Research
Austin, Texas, United States, 78754
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
PRA Health Sciences
H. Lundbeck A/S
Investigators
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Study Chair: Uma Raghunathan, MD PRA Health Sciences

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03854409     History of Changes
Other Study ID Numbers: 031-201-00279
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aripiprazole
Disease
Schizophrenia
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists