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Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia (STEP 203)

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ClinicalTrials.gov Identifier: NCT00905307
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : September 3, 2015
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: OPC-34712
Drug: Placebo
Drug: Aripiprazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

459 participants recruited at 74 study centres in the United States, Asia and Europe.

Participants not responding adequately to treatment at Week 4 visit could continue in study and receive open-label OPC-34712 (starting dose 2.5 mg/day with option for decrease to 2 mg/day or increase to 3 mg/day) until Week 6 at study physician’s discretion.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Partipants were randomized in a 1:2:2:2:2:1 ratio to the following groups:

OPC-34712 0.25 mg arm, OPC-34712 low-dose, OPC-34712 mid-dose, OPC-34712 high-dose, Placebo, Aripiprazole. All other prohibited medications were discontinued at least 24 hours before the first dose of double-blind study medication.


Reporting Groups
  Description
OPC-34712 0.25 mg 0.25 mg once daily (QD) for 6 weeks
OPC-34712 Low-dose 1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
OPC-34712 Mid-dose 2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
OPC-34712 High Dose 5.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
Aripiprazole 15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
Placebo Placebo QD for 6 weeks

Participant Flow:   Overall Study
    OPC-34712 0.25 mg   OPC-34712 Low-dose   OPC-34712 Mid-dose   OPC-34712 High Dose   Aripiprazole   Placebo
STARTED   42   89   90   93   50   95 
COMPLETED   20   52   53   56   34   53 
NOT COMPLETED   22   37   37   37   16   42 
Switched to Open Label Rescue                7                17                11                11                4                15 
Lost to Follow-up                0                0                0                0                1                1 
Adverse Event                3                4                5                11                3                5 
Withdrawal by Subject                5                13                15                11                4                13 
Protocol Violation                1                0                1                0                0                0 
Lack of Efficacy                6                3                5                4                4                8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
OPC-34712 0.25 mg 0.25 mg QD for 6 weeks
OPC-34712 Low-dose 1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
OPC-34712 Mid-dose 2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
OPC-34712 High-dose 5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
Aripiprazole 15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
Placebo Placebo QD for 6 weeks
Total Total of all reporting groups

Baseline Measures
   OPC-34712 0.25 mg   OPC-34712 Low-dose   OPC-34712 Mid-dose   OPC-34712 High-dose   Aripiprazole   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   89   90   93   50   95   459 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.4  (9.1)   39.2  (10.3)   37.4  (11.1)   39.5  (11.1)   40.8  (11)   38.8  (11.4)   39.1  (10.6) 
Gender 
[Units: Participants]
             
Female   15   36   30   38   16   37   172 
Male   27   53   60   55   34   58   287 


  Outcome Measures

1.  Primary:   Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score (Double Blind Phase)   [ Time Frame: Baseline to Week 6 ]

2.  Secondary:   Change From Baseline to Week 6 in PANSS Positive Subscale Score (Double Blind Phase)   [ Time Frame: Baseline to Week 6 ]

3.  Secondary:   Change From Baseline to Week 6 in PANSS Negative Subscale Score (Double Blind Phase)   [ Time Frame: Baseline to Week 6 ]

4.  Secondary:   Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP) (Double Blind Phase)   [ Time Frame: Baseline to Week 6 ]

5.  Secondary:   Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score (Double Blind Phase)   [ Time Frame: Baseline to Week 6 ]

6.  Secondary:   Mean Clinical Global Impression - Improvement (CGI-I) at Week 6   [ Time Frame: Week 6 ]

7.  Secondary:   Response Rate at Week 6   [ Time Frame: Week 6 ]

8.  Secondary:   Discontinuation Rate for Lack of Efficacy or Receipt of Open Label OPC-34712   [ Time Frame: Baseline to Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
phone: 800-562-3924


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00905307     History of Changes
Other Study ID Numbers: 331-07-203
First Submitted: May 19, 2009
First Posted: May 20, 2009
Results First Submitted: August 4, 2015
Results First Posted: September 3, 2015
Last Update Posted: October 20, 2015