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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01435759




Registration number
NCT01435759
Ethics application status
Date submitted
15/09/2011
Date registered
19/09/2011
Date last updated
9/06/2021

Titles & IDs
Public title
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Scientific title
A Phase 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant
Secondary ID [1] 0 0
2011-003615-28
Secondary ID [2] 0 0
SPD489-209
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Treatment: Drugs - Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Treatment: Drugs - Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Treatment: Drugs - Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Treatment: Drugs - Antidepressant + Placebo

Experimental: Antidepressant + SPD489 10 mg -

Experimental: Antidepressant + SPD489 30 mg -

Experimental: Antidepressant + SPD489 50 mg -

Experimental: Antidepressant + SPD489 70 mg -

Placebo Comparator: Antidepressant + Placebo -


Treatment: Drugs: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks

Treatment: Drugs: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks

Treatment: Drugs: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks

Treatment: Drugs: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks

Treatment: Drugs: Antidepressant + Placebo
oral, once daily for 8 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Montgomery-?sberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)
Timepoint [1] 0 0
Augmentation Baseline (Week 8) to Week 16
Secondary outcome [1] 0 0
Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
Timepoint [1] 0 0
From Augmentation Baseline (Week 8) to Week 16
Secondary outcome [2] 0 0
Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
Timepoint [2] 0 0
From Augmentation Baseline (Week 8) to Week 16
Secondary outcome [3] 0 0
Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16
Timepoint [3] 0 0
From Augmentation Baseline (Week 8) to Week 16

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Subject is able to provide written, personally signed and dated informed consent to
participate in the study before completing any study-related procedures.

2. Subject is between 18-65 years of age.

3. Subject has a primary diagnosis of non-psychotic MDD.

4. Subject has a MADRS total score 24

5. Subject is willing and has an understanding and ability to fully comply with study
procedures and restrictions defined in this protocol.

6. Subject, who is female, must have a negative serum beta human chorionic gonadotropin
(HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any
applicable contraceptive requirements.

7. Subject is able to swallow a capsule.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Subject whose current episode of MDD has not responded to an adequate treatment
regimen.

2. Subject who has a lifetime history of treatment resistant depression, defined as
having not responded to adequate treatment with 2 or more treatment regimens.

3. Subject has a current comorbid psychiatric disorder that is either controlled with
medications prohibited in this study or is uncontrolled and associated with
significant symptoms.

4. Subject has been hospitalized (within the last 12 months) for their current MDD
episode.

5. Subject has a current or lifetime history of attention-deficit/hyperactivity disorder
(ADHD).

6. Subject has a first degree relative that has been diagnosed with bipolar I disorder.

7. Subject has a recent history (within the last 6 months) of suspected substance abuse
or dependence disorder.

8. Subject is considered a suicide risk, has previously made a suicide attempt within the
past 3 years, or is currently demonstrating active suicidal ideation.

9. Subject has a concurrent chronic or acute illness or unstable medical condition.

10. Subject has a history of seizures (other than infantile febrile seizures), any tic
disorder, or a current diagnosis and/or a known family history of Tourette's Disorder,
serious neurological disease, history of significant head trauma, dementia,
cerebrovascular disease, Parkinson's disease, or intracranial lesions.

11. Subject has known history of symptomatic cardiovascular disease, advanced
arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm
abnormalities, coronary artery disease, or other serious cardiac problems that may
place them at increased vulnerability to the sympathomimetic effects of a stimulant
medication.

12. Subject has a history of thyroid disorder that has not been stabilized on thyroid
medication or treatment within 3 months prior to the Screening Visit.

13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

14. Subject has glaucoma.

15. Subject has any clinically significant ECG or clinical laboratory abnormalities at the
Screening Visit.

16. Subject has a history of moderate to severe hypertension.

17. Current use of any other medication (including over-the-counter [OTC], herbal or
homeopathic preparations) that has central nervous system effects.

18. Subject has the potential to need to initiate or modify frequency of psychotherapy or
to continue or initiate other treatments for depression, outside of those allowed in
this protocol.

19. Subject has had electroconvulsive therapy for the current depressive episode 3 months
prior to the Lead-in Baseline Visit.

20. The subject has a known or suspected intolerance or hypersensitivity to the
investigational product.

21. The subject has a known or suspected intolerance or hypersensitivity to any of the
possible antidepressant treatments (escitalopram oxalate or venlafaxine HCL extended
release.

22. Subject has a positive urine drug result.

23. Subject has a body mass index of <18.5 or >40.

24. Subject is female and is pregnant or nursing.

25. Subject has participated in another clinical study involving SPD489/NRP104 or has
previously used commercial lisdexamfetamine dimesylate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/01/2014
Sample size
Target
Accrual to date
Final
1197
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peninsula Health Mental Health Services - Frankston
Recruitment hospital [2] 0 0
Neurotherapy Victoria - Malvern
Recruitment hospital [3] 0 0
The Alfred, Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment hospital [4] 0 0
The Melbourne Clinic - Richmond
Recruitment hospital [5] 0 0
Lyell McEwin Hospital, Mental Health Clinical Trials Unit - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Caba
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Chile
State/province [26] 0 0
Il Region
Country [27] 0 0
Chile
State/province [27] 0 0
Santiago
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Warrington Cheshire
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Derby
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Horsham
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Newcastle upon Tyne
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)
who are taking certain types of antidepressants but continue to have residual depression
symptoms. The purpose of this study is to help answer the following questions:

- How safe is SPD489 for the supplemental treatment of depression and what are the side
effects that might be related to it?

- Can SPD489 help patients with depression who are also taking an antidepressant?

- How much SPD489 should be given to patients with depression who are also taking an
antidepressant?

- How does SPD489 compare to placebo in depressed patients who are also taking an
antidepressant?
Trial website
https://clinicaltrials.gov/ct2/show/NCT01435759
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01435759