Trial · NCT00985725

SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

NCT00985725, Phase 2, Completed, Shire; results first posted 2012-04-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder. Trials, record NCT00985725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00985725

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
NCT number: NCT00985725
Status: Completed
Phases: Phase 2
Enrollment: 143 participants, actual
Lead sponsor: Shire
Conditions: Major Depressive Disorder
Interventions: SPD489 (Lisdexamfetamine dimesylate), Matching placebo
First posted: 2009-09-28
Last updated: 2021-06-08
Results first posted: 2012-04-06

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)	Baseline and week 9	BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Secondary	Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)	Baseline and week 9	MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Secondary	Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	Baseline and week 9	BRIEF-A is a validated 75-item questionnaire. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Secondary	Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint	Baseline and up to 9 weeks/Endpoint	This measures the speed and accuracy of basic mental functions. Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample. Scores are normalized with a mean of 100 and standard deviation of 15. Scores \< 70 indicate likely deficit and impairment, and scores \> 110 indicate high function and capacity. Higher scores are better.
Secondary	Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline	Baseline	CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Secondary	Percent of Participants With CGI-S at up to 9 Weeks/Endpoint	Up to 9 weeks/Endpoint	CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Secondary	Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF	Week 9	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Secondary	Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint	Baseline and up to 9 weeks/Endpoint	The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance). Scores range from 0 to 100 with 100 representing lowest productivity.
Secondary	Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF	Baseline and week 9	This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.
Secondary	Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF	Baseline and week 9	This is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)	Baseline and week 9	The Full Analysis Set (FAS) defined as all randomized subjects who took at least 1 dose of randomized investigational product and had at least 1 primary efficacy assessment after baseline.	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)	Baseline and week 9	FAS	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	Baseline and week 9	FAS	T-scores	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint	Baseline and up to 9 weeks/Endpoint	FAS	Response scores	MEAN
SECONDARY	Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline	Baseline	FAS	percentage of participants	NUMBER
SECONDARY	Percent of Participants With CGI-S at up to 9 Weeks/Endpoint	Up to 9 weeks/Endpoint	FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF	Week 9	FAS	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint	Baseline and up to 9 weeks/Endpoint	FAS population was used for this assessment. However, not all subjects from the FAS completed this assessment, therefore the total number of subjects analyzed for this outcome is less than the total number of subjects that comprise the FAS population.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF	Baseline and week 9	The Safety Analysis Set (SAS) defined as all randomized subjects who took at least 1 dose of investigational product and for whom at least 1 follow-up safety assessment was completed. Only the males from the SAS population were used and not all of them completed this outcome assessment.	Scores on a scale	MEAN
SECONDARY	Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF	Baseline and week 9	Only the females from the SAS population were used and not all of them completed this outcome assessment.	Scores on a scale	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group82

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)	Lisdexamfetamine Dimesylate (LDX)		-21.2	Standard Error 1.67	T-scores
Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)	Placebo		-13.2	Standard Error 1.66	T-scores
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)	Lisdexamfetamine Dimesylate (LDX)		-5.0	Standard Error 0.66	Scores on a scale
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)	Placebo		-3.1	Standard Error 0.66	Scores on a scale
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	Lisdexamfetamine Dimesylate (LDX)	Behavioral recognition index	-17.4	Standard Error 1.51	T-scores
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	Placebo	Behavioral recognition index	-12.3	Standard Error 1.50	T-scores
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	Lisdexamfetamine Dimesylate (LDX)	Inhibit subscale	-13.5	Standard Error 1.26	T-scores
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	Placebo	Inhibit subscale	-9.3	Standard Error 1.25	T-scores
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	Lisdexamfetamine Dimesylate (LDX)	Shift subscale	-16.2	Standard Error 1.51	T-scores
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	Placebo	Shift subscale	-10.6	Standard Error 1.50	T-scores

1 to 10 of 82Source ClinicalTrials.gov

See all 82 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lisdexamfetamine Dimesylate (LDX)	71
Overall Study	STARTED	Placebo	72
Overall Study	COMPLETED	Lisdexamfetamine Dimesylate (LDX)	60
Overall Study	COMPLETED	Placebo	59
Overall Study	NOT COMPLETED	Lisdexamfetamine Dimesylate (LDX)	11
Overall Study	NOT COMPLETED	Placebo	13

Source ClinicalTrials.gov

Adverse events84

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hyperacusis	Ear and labyrinth disorders	Lisdexamfetamine Dimesylate (LDX)	2	71
other	Hyperacusis	Ear and labyrinth disorders	Placebo	0	72
other	Abdominal pain	Gastrointestinal disorders	Lisdexamfetamine Dimesylate (LDX)	1	71
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	72
other	Constipation	Gastrointestinal disorders	Lisdexamfetamine Dimesylate (LDX)	2	71
other	Constipation	Gastrointestinal disorders	Placebo	0	72
other	Diarrhea	Gastrointestinal disorders	Lisdexamfetamine Dimesylate (LDX)	2	71
other	Diarrhea	Gastrointestinal disorders	Placebo	4	72
other	Dry mouth	Gastrointestinal disorders	Lisdexamfetamine Dimesylate (LDX)	11	71
other	Dry mouth	Gastrointestinal disorders	Placebo	6	72

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lisdexamfetamine Dimesylate (LDX)
Total, all-cause mortality	Placebo
Total, other adverse events	Lisdexamfetamine Dimesylate (LDX)	56	71
Total, other adverse events	Placebo	53	72
Total, serious adverse events	Lisdexamfetamine Dimesylate (LDX)	2	71
Total, serious adverse events	Placebo	4	72

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24309905	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Lisdexamfetamine Dimesylate (LDX) vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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