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

• ClinicalTrials.gov Identifier: NCT01760889
• Recruitment Status: Terminated
• First Posted: January 4, 2013
• Results First Posted: May 29, 2014
• Last Update Posted: May 29, 2014
• Sponsor: Shire
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		SPD489 Low Dose Range	SPD489 High Dose Range	Placebo	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and week 26

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Up to 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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)
Description	[Not Specified]
Time Frame	Up to 26 weeks

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	Baseline and 26 weeks

Outcome Measure Data

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
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.

Adverse Events

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
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	--/--	--/--	--/--
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
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

Limitations and Caveats

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

More Information

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

• Name/Title: Study Physician
• Organization: Shire
• Phone: +1 866 842 5335

• 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