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Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

This study has been terminated.
(Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.)
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01738698
First received: November 28, 2012
Last updated: May 1, 2014
Last verified: May 2014
History of Changes
Results First Received: May 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: SPD489 40mg
Drug: SPD489 100mg
Drug: SPD489 160mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Reporting Groups
  Description
SPD489 40mg SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo Placebo: Oral administration once-daily for 12 weeks

Participant Flow:   Overall Study
    SPD489 40mg   SPD489 100mg   SPD489 160mg   Placebo
STARTED   0   0   0   0 
COMPLETED   0   0   0   0 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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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.
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Reporting Groups
  Description
SPD489 40mg SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
SPD489 100mg SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
SPD489 160mg SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Placebo Placebo: Oral administration once-daily for 12 weeks
Total Total of all reporting groups

Baseline Measures
   SPD489 40mg   SPD489 100mg   SPD489 160mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 0   0   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale   [ Time Frame: Baseline and week 12 ]
  Show Outcome Measure 11

12.  Secondary:   Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale   [ Time Frame: Up to 12 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Up to 12 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 14

15.  Secondary:   Ambulatory Blood Pressure Monitoring (ABPM)   [ Time Frame: Baseline and Weeks 4 and 10 ]
  Show Outcome Measure 15


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01738698     History of Changes
Other Study ID Numbers: SPD489-338
2012-003918-14 ( EudraCT Number )
Study First Received: November 28, 2012
Results First Received: May 1, 2014
Last Updated: May 1, 2014