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CompletedNCT03854409Updated Sep 2, 2020

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

A Phase 1 interventional study of Aripiprazole in Schizophrenia and Bipolar I Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Apr 2019, 7 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia
  • Bipolar I Disorder

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 72 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Part A - Deltoid Site: Single Dose Group

    Participants will receive a single dose of aripiprazole LAI.

    Drug: Aripiprazole

  • Experimental
    Part A - Gluteal Site: Single Dose Group

    Participants will receive a single dose of aripiprazole LAI.

    Drug: Aripiprazole

  • Experimental
    Part A - Deltoid Site: Multiple Dose Group

    Participants will receive five injections of aripiprazole LAI, administered at monthly intervals.

    Drug: Aripiprazole

  • Experimental
    Part A - Gluteal Site: Multiple Dose Group

    Participants will receive five injections of aripiprazole LAI, administered at monthly intervals.

    Drug: Aripiprazole

  • Experimental
    Part B - Gluteal Site: Group 1 (X)

    Participants will receive a single dose of aripiprazole LAI.

    Drug: Aripiprazole

  • Experimental
    Part B - Gluteal Site: Group 1 (Y)

    Participants will receive a single dose of aripiprazole LAI.

    Drug: Aripiprazole

  • Experimental
    Part B - Gluteal Site: Group 2

    Participants will receive a single dose of aripiprazole LAI.

    Drug: Aripiprazole

Interventions

  • DrugAripiprazole

    Injection.

    Also known as: (OPC-14597)

06

What researchers measure

Primary outcomes

  1. Part A - Single Dose Group: Maximum Observed Plasma Concentration (Cmax) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 126

  2. Part B - Group 1: Maximum Observed Plasma Concentration (Cmax) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  3. Part B - Group 2: Maximum Observed Plasma Concentration (Cmax) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  4. Part A - Single Dose Group: Plasma Concentration at 28 Days Postdose (C28) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 28

  5. Part B - Group 1: Plasma Concentration at 28 Days Postdose (C28) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 28

  6. Part B - Group 2: Plasma Concentration at 28 Days Postdose (C28) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 28

  7. Part A - Single Dose Group: Time to Reach the Maximum Plasma Concentration (Tmax) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 126

  8. Part B - Group 1: Time to Reach the Maximum Plasma Concentration (Tmax) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  9. Part B - Group 2: Time to Reach the Maximum Plasma Concentration (Tmax) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  10. Part A - Single Dose Group: Area Under the Concentration-Time Curve from time Zero to Time t (the Last Observable Concentration; AUCt) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 126

  11. Part B - Group 1: Area Under the Concentration-Time Curve from time Zero to Time t (the Last Observable Concentration; AUCt) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  12. Part B - Group 2: Area Under the Concentration-Time Curve from time Zero to Time t (the Last Observable Concentration; AUCt) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  13. Part A - Single Dose Group: Area Under the Concentration-Time Curve from Time Zero to 28 Days Postdose (AUC0-28) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 28

  14. Part B - Group 1: Area Under the Concentration-Time Curve from Time Zero to 28 Days Postdose (AUC0-28) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 28

  15. Part B - Group 2: Area Under the Concentration-Time Curve from Time Zero to 28 Days Postdose (AUC0-28) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 28

  16. Part A - Single Dose Group: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Aripiprazole (AUC∞) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 126

  17. Part B - Group 1: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Aripiprazole (AUC∞) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  18. Part B - Group 2: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for Aripiprazole (AUC∞) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  19. Part A - Single Dose Group: Terminal Phase Elimination Half-life (T1/2) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 126

  20. Part B - Group 1: Terminal Phase Elimination Half-life (T1/2) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  21. Part B - Group 2: Terminal Phase Elimination Half-life (T1/2) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 1 to Day 57

  22. Part A - Single Dose Group: Oral Clearance (CL/F) for Aripiprazole Only

    Apparent clearance of the drug from plasma after extravascular administration (CL/F).

    Time frame: Day 1 to Day 126

  23. Part B - Group 1: Oral Clearance (CL/F) for Aripiprazole Only

    Apparent clearance of the drug from plasma after extravascular administration (CL/F).

    Time frame: Day 1 to Day 57

  24. Part B - Group 2: Oral Clearance (CL/F) for Aripiprazole Only

    Apparent clearance of the drug from plasma after extravascular administration (CL/F).

    Time frame: Day 1 to Day 57

  25. Part A - Multiple Dose Group: Maximum Observed Plasma Concentration (Cmax) for Aripiprazole and Dehydro-Aripiprazole (Following the Fifth Dose Only)

    Fifth dose will be administered on Day 113.

    Time frame: Day 113 to Day 169

  26. Part A - Multiple Dose Group: Plasma Concentration at 28 Days Postdose (C28) for Aripiprazole and Dehydro-Aripiprazole

    Time frame: Day 29, Day 57, Day 84, Day 113, Day 141 (All post-dose)

  27. Part A - Multiple Dose Group: Time to Reach the Maximum Plasma Concentration (Tmax) (Following the Fifth Dose Only) for Aripiprazole and Dehydro-Aripiprazole

    Participants will receive their 5th dose on Day 113.

    Time frame: Day 113 to Day 169

  28. Part A - Multiple Dose Group: Area Under the Concentration-Time Curve from Time Zero to 28 Days Postdose (AUC0-28) (Following the Fifth Dose Only) for Aripiprazole and Dehydro-Aripiprazole

    Participants will receive their 5th dose on Day 113.

    Time frame: Day 113 to Day 169

  29. Part A - Multiple Dose Group: Terminal Phase Elimination Half-life (T1/2) (Following the Fifth Dose Only) for Aripiprazole and Dehydro-Aripiprazole

    Participants will receive their 5th dose on Day 113.

    Time frame: Day 113 to Day 169

  30. Part A - Multiple Dose Group: Oral Clearance (CL/F) (Following the Fifth Dose Only; for Aripiprazole Only)

    Participants will receive their 5th dose on Day 113.

    Time frame: Day 113 to Day 169

  31. Part A - Multiple Dose Group: Ratio of Dehydro-Aripiprazole to Aripiprazole C28 and AUC0-28 (Following the Fifth Dose Only)

    Participants will receive their 5th dose on Day 113.

    Time frame: Day 113 (following fifth dose) to Day 141

Secondary outcomes

  1. Part A - Single Dose: Number of Participants with an Adverse Event (AE)

    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.

    Time frame: Day 1 to End of Trial (Maximum 126 Days from First Dose)

  2. Part A - Multiple Dose: Number of Participants with an Adverse Event (AE)

    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.

    Time frame: Day 1 to End of Trial (Maximum 169 Days from First Dose)

  3. Part B: Number of Participants with an Adverse Event (AE)

    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.

    Time frame: Day 1 to End of Trial (Maximum 57 Days from First Dose)

  4. Part A - Single Dose: Number of Participants with Markedly Abnormal Vital Sign Measurements

    Vital signs will be obtained prior to PK blood draws. Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  5. Part A - Multiple Dose: Number of Participants with Markedly Abnormal Vital Sign Measurements

    Vital signs will be obtained prior to PK blood draws. Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  6. Part B: Number of Participants with Markedly Abnormal Vital Sign Measurements

    Vital signs will be obtained prior to PK blood draws. Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  7. Part A - Single Dose: Number of Participants with Markedly Abnormal Electrocardiograms (ECGs) Results

    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.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  8. Part A - Multiple Dose: Number of Participants with Markedly Abnormal Electrocardiograms (ECGs) Results

    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.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  9. Part B: Number of Participants with Markedly Abnormal Electrocardiograms (ECGs) Results

    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.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  10. Part A - Single Dose: Number of Participants with Markedly Abnormal Clinical Laboratory Results

    Clinical Laboratory Monitoring includes serum chemistry, hematology and urinalysis.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  11. Part A - Multiple Dose: Number of Participants with Markedly Abnormal Clinical Laboratory Results

    Clinical Laboratory Monitoring includes serum chemistry, hematology and urinalysis.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  12. Part B: Number of Participants with Markedly Abnormal Clinical Laboratory Results

    Clinical Laboratory Monitoring includes serum chemistry, hematology and urinalysis.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  13. Part A - Single Dose: Change from Baseline in Serum Prolactin

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  14. Part A - Multiple Dose: Change from Baseline in Serum Prolactin

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  15. Part B: Change from Baseline in Serum Prolactin

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  16. Part A - Single Dose: Number of Participants with Markedly Abnormal Physical Examination Results

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  17. Part A - Multiple Dose: Number of Participants with Markedly Abnormal Physical Examination Results

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  18. Part B: Number of Participants with Markedly Abnormal Physical Examination Results

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  19. Part A - Single Dose: Visual Analog Scale (VAS) Scores for Injection Site Pain Perception

    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.

    Time frame: Day 1 immediately post-dose, 1 hour post-dose (+/- 15 minutes), Day 14 and Day 29

  20. Part A - Multiple Dose: Visual Analog Scale (VAS) Scores for Injection Site Pain Perception

    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.

    Time frame: 1-hour post-dose Day 1, Day 29, Day 57, Day 85, Day 113

  21. Part B: Visual Analog Scale (VAS) Scores for Injection Site Pain Perception

    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.

    Time frame: Day 1 immediately post-dose, 1 hour post-dose (+/- 15 minutes), Day 14 and Day 29

  22. Part A - Single Dose: Change from Baseline of Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  23. Part A - Multiple Dose: Change from Baseline of Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  24. Part B: Change from Baseline of Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  25. Part A - Single Dose: Number of Injection Site Related Adverse Events

    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.

    Time frame: End of Trial (Maximum 126 Days from First Dose)

  26. Part A - Multiple Dose: Number of Injection Site Related Adverse Events

    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.

    Time frame: End of Trial (Maximum 169 Days from First Dose)

  27. Part B: Number of Injection Site Related Adverse Events

    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.

    Time frame: End of Trial (Maximum 57 Days from First Dose)

  28. Part A - Single Dose: Change from Baseline in Assessment of Extrapyramidal Symptoms (EPS)

    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.

    Time frame: Day 1 (predose) to End of Trial (Maximum 126 Days from First Dose)

  29. Part A - Multiple Dose: Change from Baseline in Assessment of Extrapyramidal Symptoms (EPS)

    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.

    Time frame: Day 1 (predose) to End of Trial (Maximum 169 Days from First Dose)

  30. Part B: Change from Baseline in Assessment of Extrapyramidal Symptoms (EPS)

    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.

    Time frame: Day 1 (predose) to End of Trial (Maximum 57 Days from First Dose)

  31. Part A - Single Dose: Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  32. Part A - Multiple Dose: Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  33. Part B: Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  34. Part A - Single Dose: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  35. Part A - Multiple Dose: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  36. Part B: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  37. Part A - Single Dose: Change from Baseline in Subjective Well-being under Neuroleptic Treatment-Short Form (SWN-S) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  38. Part A - Multiple Dose: Change from Baseline in Subjective Well-being under Neuroleptic Treatment-Short Form (SWN-S) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  39. Part B: Change from Baseline in Subjective Well-being under Neuroleptic Treatment-Short Form (SWNS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  40. Part A - Single Dose: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  41. Part A - Multiple Dose: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  42. Part B: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  43. Part A - Single Dose: Change from Baseline in Young Mania Rating Scale (YMRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  44. Part A - Multiple Dose: Change from Baseline in Young Mania Rating Scale (YMRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  45. Part B: Change from Baseline in Young Mania Rating Scale (YMRS) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

  46. Part A - Single Dose: Change from Baseline in Clinical Global Impression-Bipolar Version (CGI-BP) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

  47. Part A - Multiple Dose: Change from Baseline in Clinical Global Impression-Bipolar Version (CGI-BP) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

  48. Part B: Change from Baseline in Clinical Global Impression-Bipolar Version (CGI-BP) Score

    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.

    Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

07

Study locations

4 sites
  • Woodland International Research Group
    Little Rock, Arkansas 72211, United States
  • Collaborative Neuroscience Network
    Garden Grove, California 92845, United States
  • Hassman Research Institute
    Berlin, New Jersey 08009, United States
  • Community Clinical Research
    Austin, Texas 78754, United States
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03854409
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
PRA Health Sciences, H. Lundbeck A/S
Responsible party
Sponsor
First posted
Feb 26, 2019
Start date
Jan 31, 2019
Primary completion
Apr 5, 2019
Completion
Feb 20, 2020
Last update
Sep 2, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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