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

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: NCT01646827
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : July 31, 2014
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Schizophrenia
Intervention Drug: Aripiprazole IM Depot
Enrollment 37
Recruitment Details This report presents results of a study on 37 adults with schizophrenia, conducted at 6 centers in the United States.
Pre-assignment Details 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.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle. The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Period Title: Overall Study
Started 18 19
Completed 16 14
Not Completed 2 5
Reason Not Completed
Lost to Follow-up             0             3
Physician Decision             1             2
Withdrawal by Subject             1             0
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal Total
Hide Arm/Group Description The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle. The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle. Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 37 participants
43.1  (11.0) 45.9  (7.3) 44.5  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
6
  33.3%
4
  21.1%
10
  27.0%
Male
12
  66.7%
15
  78.9%
27
  73.0%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Aripriprazole
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
170  (58.6) 136  (70.3)
2.Primary Outcome
Title 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
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: ng day/mL
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)
3.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
51.7  (23.3) 34.6  (13.2)
4.Primary Outcome
Title 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
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: ng day/mL
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)
5.Secondary Outcome
Title Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).
Hide Description Safety was measured according to standard adverse event collection as described in the adverse event section of the results.
Time Frame Starting at the time the ICF was signed to Day 126/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: Participants
Subjects with TEAEs 14 18
Subjects with serious TEAEs 0 0
Subjects with severe TEAEs 1 1
6.Secondary Outcome
Title Number of Participants With Laboratory Values of Potential Clinical Relevance.
Hide Description 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.
Time Frame Day 1, Day 28, Day 126/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: Participants
High fasting triglycerides (n=9,11) 3 5
High fasting glucose (n=9,11) 3 0
High prolactin (n=17,18) 3 3
Low absolute neutrophils (n=17,18) 1 2
High creatine phosphokinase (n=17,18) 2 0
7.Secondary Outcome
Title Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure
Hide Description 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.
Time Frame Day 1, Day 14, Day 28 and Day 126/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: Participants
Increase >/=15 mmHg in diastolic standing BP 0 1
Orthostatic hypotension 0 0
8.Secondary Outcome
Title Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature
Hide Description Vital sign assessment included body temperature measured in centigrade(C). Temperatures >=37.8°C and increase of >= 1.1°C were recorded.
Time Frame Day 1, Day 14, Day 28 and Day 126/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: Participants
0 0
9.Secondary Outcome
Title Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate
Hide Description Vital sign assessment included heart rate (supine and standing). Heart rate with increase or decrease of >/= 15 beats per minute were recorded.
Time Frame Day 1, Day 14, Day 28 and Day 126/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: Participants
Heart rate: Supine: increase 0 0
Heart rate: Supine: decrease 0 0
Heart rate: Standing: increase 0 0
Heart rate: Standing: decrease 0 0
10.Secondary Outcome
Title Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance
Hide Description 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.
Time Frame Day 1, Day 14, Day 28 and Day 126/Early termination
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: Participants
premature ventricular contractions 2 1
T-wave inversions 2 2
Bradycardia and sinus bradycardia 0 1
Abnormalities in QTc intervals 0 0
11.Secondary Outcome
Title Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.
Hide Description 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.
Time Frame Day 1, Day 14, Day 28 and last visit
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 17 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1: 0.5 hour pre-dose (n=17, 18) 1.2  (3.4) 0.8  (1.6)
Day 1: 1 hour post-dose (n=17, 18) 3.1  (7.3) 1.7  (2.7)
Day 14 (n=16, 18) 1.3  (3.7) 0.3  (0.8)
Day 28 (n=16, 18) 0.5  (1.1) 0.5  (1.3)
Last visit (n=17, 18) 2.2  (7.2) 0.5  (1.3)
12.Secondary Outcome
Title Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.
Hide Description 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.
Time Frame Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description:
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
Overall Number of Participants Analyzed 17 18
Measure Type: Number
Unit of Measure: Participants
Screening: Suicidality (n=17,18) 4 7
Screening: Suicidal behaviour (n=17,18) 2 5
Screening: Suicidal ideation (n=17,18) 4 7
Baseline: Suicidality (n=17,18) 0 0
Baseline: Suicidal behaviour (n=17,18) 0 0
Baseline: Suicidal ideation (n=17,18) 0 0
Week 1: Suicidality (n=17,18) 0 0
Week 1: Suicidal behaviour (n=17,18) 0 0
Week 1: Suicidal ideation (n=17,18) 0 0
Week 2: Suicidality (n=16,18) 0 0
Week 2: Suicidal behaviour (n=16,18) 0 0
Week 2: Suicidal ideation (n=16,18) 0 0
Week 8: Suicidality (n=16,18) 0 0
Week 8: Suicidal behaviour (n=16,18) 0 0
Week 8: Suicidal ideation (n=16,18) 0 0
Week 18: Suicidality (n=16,14) 0 0
Week 18: Suicidal behaviour (n=16,14) 0 0
Week 18: Suicidal ideation (n=16,14) 0 0
Last visit: Suicidality (n=17,18) 0 0
Last visit: Suicidal behaviour (n=17,18) 0 0
Last visit: Suicidal ideation (n=17,18) 0 0
Time Frame Events were recorded starting at the time the ICF is signed up to 125 days after the study drug administration.
Adverse Event Reporting Description 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.
 
Arm/Group Title Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Hide Arm/Group Description The participants in this group received single aripiprazole IM depot (400 mg) injection in the deltoid muscle. The participants in this group received single aripiprazole IM depot (400 mg) injection in the gluteal muscle.
All-Cause Mortality
Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole IM Depot 400 mg: Deltoid Aripiprazole IM Depot 400 mg: Gluteal
Affected / at Risk (%) Affected / at Risk (%)
Total   14/17 (82.35%)   18/18 (100.00%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  1/17 (5.88%)  1/18 (5.56%) 
Abdominal pain upper * 1  0/17 (0.00%)  1/18 (5.56%) 
Constipation * 1  1/17 (5.88%)  1/18 (5.56%) 
Diarrhoea * 1  2/17 (11.76%)  1/18 (5.56%) 
Dry mouth * 1  0/17 (0.00%)  2/18 (11.11%) 
Dyspepsia * 1  0/17 (0.00%)  1/18 (5.56%) 
Gastrooesophageal reflux disease * 1  0/17 (0.00%)  1/18 (5.56%) 
Gingival pain * 1  1/17 (5.88%)  0/18 (0.00%) 
Nausea * 1  1/17 (5.88%)  2/18 (11.11%) 
Salivary hypersecretion * 1  1/17 (5.88%)  0/18 (0.00%) 
Toothache * 1  2/17 (11.76%)  1/18 (5.56%) 
Vomiting * 1  1/17 (5.88%)  2/18 (11.11%) 
General disorders     
Axillary pain * 1  0/17 (0.00%)  1/18 (5.56%) 
Chills * 1  1/17 (5.88%)  0/18 (0.00%) 
Fatigue * 1  0/17 (0.00%)  1/18 (5.56%) 
Injection site pain * 1  6/17 (35.29%)  5/18 (27.78%) 
Injection site rash * 1  1/17 (5.88%)  0/18 (0.00%) 
Non-cardiac chest pain * 1  0/17 (0.00%)  1/18 (5.56%) 
Pain * 1  1/17 (5.88%)  0/18 (0.00%) 
Infections and infestations     
Furuncle * 1  0/17 (0.00%)  1/18 (5.56%) 
Hordeolum * 1  0/17 (0.00%)  1/18 (5.56%) 
Infected bites * 1  0/17 (0.00%)  1/18 (5.56%) 
Tooth abscess * 1  1/17 (5.88%)  0/18 (0.00%) 
Upper respiratory tract infection * 1  0/17 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications     
Excoriation * 1  1/17 (5.88%)  0/18 (0.00%) 
Laceration * 1  1/17 (5.88%)  0/18 (0.00%) 
Meniscus lesion * 1  1/17 (5.88%)  0/18 (0.00%) 
Investigations     
Blood creatine phosphokinase increased * 1  2/17 (11.76%)  0/18 (0.00%) 
Blood glucose increased * 1  1/17 (5.88%)  0/18 (0.00%) 
Blood triglycerides increased * 1  1/17 (5.88%)  0/18 (0.00%) 
Electrocardiogram T wave inversion * 1  1/17 (5.88%)  0/18 (0.00%) 
Glucose urine present * 1  1/17 (5.88%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/17 (11.76%)  1/18 (5.56%) 
Back pain * 1  1/17 (5.88%)  1/18 (5.56%) 
Muscle spasms * 1  0/17 (0.00%)  1/18 (5.56%) 
Musculoskeletal pain * 1  3/17 (17.65%)  2/18 (11.11%) 
Musculoskeletal stiffness * 1  1/17 (5.88%)  0/18 (0.00%) 
Myalgia * 1  1/17 (5.88%)  0/18 (0.00%) 
Pain in extremity * 1  0/17 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
Akathisia * 1  3/17 (17.65%)  3/18 (16.67%) 
Dizziness * 1  0/17 (0.00%)  3/18 (16.67%) 
Dyskinesia * 1  1/17 (5.88%)  1/18 (5.56%) 
Dystonia * 1  1/17 (5.88%)  1/18 (5.56%) 
Extrapyramidal disorder * 1  1/17 (5.88%)  0/18 (0.00%) 
Headache * 2  4/17 (23.53%)  4/18 (22.22%) 
Sedation * 1  1/17 (5.88%)  2/18 (11.11%) 
Somnolence * 1  3/17 (17.65%)  0/18 (0.00%) 
Tremor * 1  0/17 (0.00%)  1/18 (5.56%) 
Psychiatric disorders     
Agitation * 1  1/17 (5.88%)  2/18 (11.11%) 
Anxiety * 1  1/17 (5.88%)  1/18 (5.56%) 
Conversion disorder * 1  0/17 (0.00%)  1/18 (5.56%) 
Insomnia * 1  2/17 (11.76%)  2/18 (11.11%) 
Restlessness * 1  0/17 (0.00%)  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  1/17 (5.88%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritis * 1  0/17 (0.00%)  1/18 (5.56%) 
Rash * 1  0/17 (0.00%)  1/18 (5.56%) 
Seborrhoeic dermatitis * 1  0/17 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Hypotension * 1  0/17 (0.00%)  1/18 (5.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
2
Term from vocabulary, v
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01646827     History of Changes
Other Study ID Numbers: 31-11-290
First Submitted: June 18, 2012
First Posted: July 20, 2012
Results First Submitted: April 30, 2014
Results First Posted: July 31, 2014
Last Update Posted: July 31, 2014