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Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole

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ClinicalTrials.gov Identifier: NCT01552772
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : September 9, 2014
Last Update Posted : October 10, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Aripiprazole IM Depot
Enrollment 60
Recruitment Details Trial to assess the safety and tolerability of aripiprazole intramuscular (IM) depot as an adjunctive therapy in adults with schizophrenia who were stabilized on any one of the atypical oral antipsychotics other than aripiprazole. In the United States, the trial was conducted in 60 enrolled participants and were screened in 12 centres.
Pre-assignment Details The study consisted of a 30-day Screening period, a treatment phase of 28 days, and a Follow-up at 30 days after the last trial visit. Participants must have been stabilized on one of the following atypical oral antipsychotic medications for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone.
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Period Title: Overall Study
Started 60
Completed 56 [1]
Not Completed 4
Reason Not Completed
Lost to Follow-up             2
Adverse Event             1
Protocol Deviation             1
[1]
Participants who completed the Day 28 visit were defined as completers for the trial.
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
43.2  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
10
  16.7%
Male
50
  83.3%
1.Primary Outcome
Title Number of Participants With Adverse Events (AE).
Hide Description An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the study physician. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. TEAE stands for treatment emergent adverse events.
Time Frame From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analyses dataset consisted of data from all enrolled participants who received one dose of trial medication, regardless of any protocol deviation. All observed data for these participants were included.
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: Participants
Participants with TEAE 35
Participants with serious TEAE 1
2.Secondary Outcome
Title Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline, Week 1, 2, 4 and Last visit (Day 28).
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) -2.42  (5.57)
Week 2 (N= 56) -2.86  (7.98)
Week 4 (N= 57) -3.82  (8.34)
Last visit (N= 59) -3.68  (8.26)
3.Secondary Outcome
Title Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline, Week 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety extrapyramidal symptoms (EPS) assessment scales.
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) -2.42  (5.91)
Week 2 (N= 59) -2.80  (7.83)
Week 4 (N= 59) -3.68  (8.26)
4.Secondary Outcome
Title Change From Baseline in PANSS Positive Sub-scale Score for OC Data.
Hide Description The Positive and Negative Syndrome Scale (PANSS) consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline, Week 1, 2, 4 and Last visit (Day 28).
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) -0.81  (2.45)
Week 2 (N= 56) -0.79  (3.37)
Week 4 (N= 57) -1.28  (2.89)
Last visit (N= 59) -1.25  (2.84)
5.Secondary Outcome
Title Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline, Week 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) -0.81  (2.45)
Week 2 (N= 59) -0.78  (3.29)
Week 4 (N= 59) -1.25  (2.84)
6.Secondary Outcome
Title Change From Baseline in PANSS Negative Sub-scale Score for OC Data.
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline, Week 1, 2, 4 and Last visit (Day 28).
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) -0.78  (2.30)
Week 2 (N= 56) -1.14  (2.88)
Week 4 (N= 57) -0.96  (2.88)
Last visit (N= 59) -0.92  (2.84)
7.Secondary Outcome
Title Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.
Hide Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame Baseline, Week 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) -0.78  (2.30)
Week 2 (N= 59) -1.08  (2.82)
Week 4 (N= 59) -0.92  (2.84)
8.Secondary Outcome
Title Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.
Hide Description The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 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 participants.
Time Frame Baseline, Week 1, 2, 4 and Last visit (Day 28).
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) 0.02  (0.39)
Week 2 (N= 56) -0.09  (0.35)
Week 4 (N= 57) -1.14  (0.64)
Last visit (N= 59) -1.14  (0.63)
9.Secondary Outcome
Title Change From Baseline in CGI-S Score in LOCF Data.
Hide Description The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: “Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?” Response choices included: 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 participants.
Time Frame Baseline, Week 1, 2 and 4.
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) 0.02  (0.39)
Week 2 (N= 59) -0.08  (0.34)
Week 4 (N= 59) -0.14  (0.63)
10.Secondary Outcome
Title Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.
Hide Description The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.
Time Frame Week 1, 2, 4 and Last visit (Day 28).
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) 3.85  (0.45)
Week 2 (N= 56) 3.70  (0.57)
Week 4 (N= 57) 3.56  (0.78)
Last visit (N= 59) 3.58  (0.77)
11.Secondary Outcome
Title CGI-I Scale Score in LOCF Data.
Hide Description The efficacy of trial medication were rated for each participant using the Clinical Global Impression Improvement (CGI-I) scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.
Time Frame Week 1, 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.
Arm/Group Title Total
Hide Arm/Group Description:
Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 1 (N= 59) 3.85  (0.45)
Week 2 (N= 59) 3.69  (0.56)
Week 4 (N= 59) 3.58  (0.77)
Time Frame From the time the ICF was signed until follow-up at 30 days after the last trial visit (Day 28).
Adverse Event Reporting Description SAE was any untoward medical occurrence that resulted in death, life-threatening, required inpatient hospitalization or prolonged hospitalization. AE was an exacerbation of an existing problem, any new problem, experienced by a participant in a trial, whether or not considered drug related by study physician.
 
Arm/Group Title Aripiprazole IM Depot 400mg
Hide Arm/Group Description Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
All-Cause Mortality
Aripiprazole IM Depot 400mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole IM Depot 400mg
Affected / at Risk (%)
Total   1/60 (1.67%) 
Psychiatric disorders   
Suicide Attempt * 1  1/60 (1.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aripiprazole IM Depot 400mg
Affected / at Risk (%)
Total   35/60 (58.33%) 
Gastrointestinal disorders   
Constipation * 1  1/60 (1.67%) 
Diarrhoea * 1  1/60 (1.67%) 
Dry mouth * 1  1/60 (1.67%) 
Dyspepsia * 1  1/60 (1.67%) 
Gastritis * 1  1/60 (1.67%) 
Salivary hypersecretion * 1  2/60 (3.33%) 
Toothache * 1  4/60 (6.67%) 
Vomiting * 1  1/60 (1.67%) 
General disorders   
Chest pain * 1  1/60 (1.67%) 
Fatigue * 1  3/60 (5.00%) 
Injection site pain * 1  4/60 (6.67%) 
Irritability * 1  1/60 (1.67%) 
Malaise * 1  1/60 (1.67%) 
Oedema peripheral * 1  1/60 (1.67%) 
Infections and infestations   
Nasopharyngitis * 1  1/60 (1.67%) 
Tooth abscess * 1  1/60 (1.67%) 
Upper respiratory tract infection * 1  1/60 (1.67%) 
Injury, poisoning and procedural complications   
Procedural pain * 1  1/60 (1.67%) 
Thermal burn * 1  1/60 (1.67%) 
Investigations   
Blood creatine phosphokinase increased * 1  3/60 (5.00%) 
Gamma-glutamyltransferase increased * 1  1/60 (1.67%) 
Heart rate increased * 1  1/60 (1.67%) 
Weight increased * 1  1/60 (1.67%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  2/60 (3.33%) 
Increased appetite * 1  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/60 (1.67%) 
Costochondritis * 1  1/60 (1.67%) 
Joint stiffness * 1  2/60 (3.33%) 
Muscle spasms * 1  1/60 (1.67%) 
Muscular weakness * 1  1/60 (1.67%) 
Musculoskeletal pain * 1  2/60 (3.33%) 
Musculoskeletal stiffness * 1  1/60 (1.67%) 
Neck pain * 1  1/60 (1.67%) 
Osteoarthritis * 1  1/60 (1.67%) 
Nervous system disorders   
Akathisia * 1  2/60 (3.33%) 
Disturbance in attention * 1  1/60 (1.67%) 
Dizziness * 1  1/60 (1.67%) 
Dystonia * 1  3/60 (5.00%) 
Extrapyramidal disorder * 1  1/60 (1.67%) 
Headache * 1  1/60 (1.67%) 
Sedation * 1  1/60 (1.67%) 
Tremor * 1  2/60 (3.33%) 
Psychiatric disorders   
Impatience * 1  1/60 (1.67%) 
Insomnia * 1  3/60 (5.00%) 
Restlessness * 1  3/60 (5.00%) 
Renal and urinary disorders   
Proteinuria * 1  1/60 (1.67%) 
Pyuria * 1  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/60 (1.67%) 
Cough * 1  1/60 (1.67%) 
Nasal congestion * 1  1/60 (1.67%) 
Skin and subcutaneous tissue disorders   
Rash * 1  1/60 (1.67%) 
Skin discolouration * 1  1/60 (1.67%) 
Skin nodule * 1  1/60 (1.67%) 
Vascular disorders   
Hypertension * 1  1/60 (1.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01552772     History of Changes
Other Study ID Numbers: 31-11-289
First Submitted: February 13, 2012
First Posted: March 13, 2012
Results First Submitted: September 2, 2014
Results First Posted: September 9, 2014
Last Update Posted: October 10, 2014