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SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

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ClinicalTrials.gov Identifier: NCT01760889
Recruitment Status : Terminated (Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized)
First Posted : January 4, 2013
Results First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: SPD489 low dose range (40mg, 80mg, and 100mg)
Drug: SPD489 high dose range (120mg, 140mg and 160mg)
Drug: Placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Period Title: Overall Study
Started 0 0 0
Completed 0 0 0
Not Completed 0 0 0
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo Total
Hide Arm/Group Description

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 0
Hide Baseline Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
Female
Male
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 0 participants 0 participants
1.Primary Outcome
Title Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Hide Description [Not Specified]
Time Frame Baseline and week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Hide Description [Not Specified]
Time Frame Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description [Not Specified]
Time Frame Up to 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks
Hide Description [Not Specified]
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description:

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
 
Arm/Group Title SPD489 Low Dose Range SPD489 High Dose Range Placebo
Hide Arm/Group Description

SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once-daily for 4 weeks; then,
  • 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,

  • 40 mg capsule once-daily for 1 week; then
  • 80 mg capsule once daily for 1 week; then
  • 120 mg capsule once-daily for 1 week, then,
  • 140 mg capsule once-daily for 2 weeks, then
  • 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
  • if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks
Placebo: One capsule a day for 26 weeks
All-Cause Mortality
SPD489 Low Dose Range SPD489 High Dose Range Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
SPD489 Low Dose Range SPD489 High Dose Range Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SPD489 Low Dose Range SPD489 High Dose Range Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire
Phone: +1 866 842 5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01760889    
Other Study ID Numbers: SPD489-335
2012-003919-57 ( EudraCT Number )
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: May 1, 2014
Results First Posted: May 29, 2014
Last Update Posted: May 29, 2014