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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidexamfetamine Dimesylate | Experimental | Lisdexamfetamine dimesylate (Vyvanse) is a central nervous system (CNS) stimulant, approved for the treatment of ADHD Lisdexamfetamine dimesylate is to be started at a dose of 30 mg/day for one week, increased to 50 mg/day for week 2 and to 70 mg/day for week 3. Doses are increased to the maximally tolerated/efficacious dose. Thirty milligrams of Lisdexamfetamine dimesylate per day, is the minimum dose that must be achieved. Duration of treatment in this arm is 8 weeks; tablet is taken once per day |
|
| Placebo | Placebo Comparator | Placebo will be dosed in the same fashion as the active intervention - 3 potential dose levels. Placebo is taken once per day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD Rating Scale | Change from Baseline to Week 18 | |
| Clinical Global Impression - Improvement Scale (CGI-I) | Change from Week 1 to Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Yale Global Tic Severity Scale (YGTSS) | Change from Baseline to Week 18 | |
| the Overall Anxiety Severity and Impairment Scale (OASIS) | Change from Baseline to Week 18 | |
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Inclusion Criteria:
6. Written informed consent given prior to entering the baseline period of the study.
7. All women of child bearing potential must have a negative screening visit serum or urine pregnancy test and be using adequate contraception for the duration of the study. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to provide additional protection against accidental pregnancy.
8. Concomitant treatment with selective serotonin reuptake inhibitors (SSRI's), serotonin noradrenaline reuptake inhibitors (SNRI's), benzodiazepines, beta-blockers, atypical anti-psychotics, anti-epileptics is allowed, provided the dose has been stable for 8 weeks prior to study entry. Dose changes of allowed concomitant medication should be avoided during the treatment phases of the study.
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Exclusion Criteria:
The exclusion criteria must continue to be satisfied in order for the patient to enter the randomization phase at the end of the baseline.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Collins, MBChB, FRCPC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Anxiety, Attention Deficit and Trauma | Hamilton | Ontario | L8S 1B7 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Drug |
|
| The Weiss Functional Impairment Rating Scale-Self Report (WFIRS-S) |
| Change from Baseline to Week 18 |
| Barkley Adult ADHD Rating Scale--IV(BAARS-IV) | Change from Baseline to Week 18 |
| Revised Padua Inventory | Change from Baseline to Week 18 |
| The Panic and Agoraphobia Scale (PAS) | Change from Baseline to Week 18 |
| Quick Inventory of Depressive Symptoms (QID-SR-16) | Change from Baseline to Week 18 |
| The Sheehan Disability Scale (SDS) | Change from Baseline to Week 18 |
| GAD-7 | Change from Baseline to Week 18 |
| Social Phobia Inventory (SPIN) | Change from Baseline to Week 18 |
| The Life Events Questionnaire (LEQ) | Visit 2 (Week: Baseline) |
| The Pittsburgh Sleep Quality Index (PSQI) | Change from Baseline to Week 18 |
| Clinical Global Impression - Severity (CGI-S) | Change from Baseline to Week 18 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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