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The purpose of this study is to determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deltoid | Experimental | Deltoid injection site |
|
| Gluteal | Experimental | Gluteal injection site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole IM Depot | Drug | One injection of 400 mg aripiprazole IM depot |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Starting at the time the ICF was signed to Day 126/Early termination |
| Number of Participants With Laboratory Values of Potential Clinical Relevance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Peters-Strickland, MD | Otsuka Pharmaceutical Development & Commercialization, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Development, Inc. | Cerritos | California | 90703 | United States | ||
| Collaborative Neuroscience Network, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28204607 | Derived | 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. |
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Participants were randomized 1:1 to receive a single dose of aripiprazole intramuscular (IM) depot (400 mg) in either the deltoid muscle or gluteal muscle according to the randomization schedule.
This report presents results of a study on 37 adults with schizophrenia, conducted at 6 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole IM Depot 400 mg: Deltoid | The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle. |
| FG001 | Aripiprazole IM Depot 400 mg: Gluteal |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit. |
| Garden Grove |
| California |
| 92845 |
| United States |
| CNRI - San Diego | San Diego | California | 92102 | United States |
| Neuropsychiatric Research Center of Orange County | Santa Ana | California | 92701 | United States |
| Comprehensive Clinical Development, Inc. | Washington D.C. | District of Columbia | 20016 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole IM Depot 400 mg: Deltoid | The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle. |
| BG001 | Aripiprazole IM Depot 400 mg: Gluteal | The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
|
| ||||||||||||||||||||||||||||
| Primary | 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. | The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters. | Posted | Mean | Standard Deviation | ng day/mL | 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 |
|
| |||||||||||||||||||||||||||||
| Primary | 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. | The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
| |||||||||||||||||||||||||||||
| Primary | 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. | The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters. | Posted | Mean | Standard Deviation | ng day/mL | 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 | 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. | Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation. | Posted | Number | Participants | Starting at the time the ICF was signed to Day 126/Early termination |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation. | Posted | Number | Participants | Day 1, Day 28, Day 126/Early termination |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation. | Posted | Number | Participants | Day 1, Day 14, Day 28 and Day 126/Early termination |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation. | Posted | Number | Participants | Day 1, Day 14, Day 28 and Day 126/Early termination |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation. | Posted | Number | Participants | Day 1, Day 14, Day 28 and Day 126/Early termination |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation. | Posted | Number | Participants | Day 1, Day 14, Day 28 and Day 126/Early termination |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation. | Posted | Mean | Standard Deviation | Units on a scale | Day 1, Day 14, Day 28 and last visit |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation. | Posted | Number | Participants | Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit. |
|
|
Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
All randomized participants who received at least one dose of study drug (aripiprazole IM depot 400 mg), regardless of any protocol violation were included in the safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole IM Depot 400 mg: Deltoid | The participants in this group received single aripiprazole IM depot (400 mg) injection in the deltoid muscle. | 0 | 17 | 14 | 17 | ||
| EG001 | Aripiprazole IM Depot 400 mg: Gluteal | The participants in this group received single aripiprazole IM depot (400 mg) injection in the gluteal muscle. | 0 | 18 | 18 | 18 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Infected bites | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | v | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 15.0 | Non-systematic Assessment |
|
There is no agreement between PI and sponsor that restricts the PI's right to discuss or publish trial results after the trial is completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs | Otsuka Pharmaceutical Development & Commercialization, Inc | 800 562-3974 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
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| Counts |
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| Participants |
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