Attention Deficit/Hyperactivity DisorderNCT01263548
To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder
An observational study of Attention Deficit/Hyperactivity Disorder and Bipolar Disorder, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
ADHD in the adult population is associated with several measures of harmful dysfunction. For example, adult ADHD is associated with high rates of separation/divorce and never-married status, lower educational attainment and occupational achievement, absenteeism, presenteeism, and job termination, as well as decreased… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder, Bipolar Disorder
- What is being tested?
- lisdexamfetamine dimesylate
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals who have a diagnosis of Bipolar Disorder and ADHD.
Who may be able to join
- Outpatient status
- Male or female subjects between the ages of 18 to 55 years, inclusive
- Primary diagnosis of Bipolar Disorder and ADHD according to criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) using the Mini International Neuropsychiatric Interview.
- Agree to use reliable method of birth control
- YMRS score </= 12
- CGI-BP < 6
- Able and willing to provide a written informed consent
Who cannot join
- Current Axis I primary psychiatric diagnosis other than Bipolar Disorder and ADHD
- Current Axis II psychiatric disorder of primary clinical focus
- Active alcohol as well as illicit or other substance abuse during the past 3 months
- Current clinically unstable medical condition.
- Inability to understand and engage in the process of informed consent.
- Inability to cooperate with study procedures.
Show all 12Show fewer
- Presence of known allergies or hypersensitivity to lisdexamfetamine
- History of destabilization when exposed to psychostimulant medication
- Current high risk of suicide
- Current treatment with corticosteroids
- Electroconvulsive therapy in the last 1 year
- Current participation in a separate clinical research study involving an investigational drug
Trial locations and contacts
1 site in 1 country.
About this study
ADHD in the adult population is associated with several measures of harmful dysfunction. For example, adult ADHD is associated with high rates of separation/divorce and never-married status, lower educational attainment and occupational achievement, absenteeism, presenteeism, and job termination, as well as decreased social function. Individuals with adult ADHD are more likely than controls to have a comorbid diagnosis of bipolar disorder, alcohol and substance abuse, as well as antisocial personality disorder.
Psychostimulants are the most frequently employed medications in the treatment of adult ADHD. Several psychostimulants are Health Canada and US FDA-approved for the treatment of ADHD symptoms in adulthood.
Read more
Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the treatment of ADHD symptomatology in adult individuals with bipolar disorder.
Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric) ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion, lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a longer duration of effect consistent throughout the day with reduced potential for risk of abuse. Vyvanse is generally well tolerated with an adverse event profile similar to other psychostimulant medications. Available evidence indicates that in most treated subjects, Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some individuals, it is associated with improvement in both glucose and lipid homeostasis.
The evaluation of safety/tolerability profiles as well as the effectiveness of lisdexamfetamine in a "real-world" population has significant translational value.
- Being tested
- lisdexamfetamine dimesylate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lisdexamfetamine dimesylateDrug
Also called Vyvanse
Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vyvanse | This is an open-label study which means that all study participants will be taking active study medication, Vyvanse. Receives: Drug: lisdexamfetamine dimesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic parameters
Weight; BMI; Waist circumference
Measured: Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits
Secondary outcomes (6)
ADHD-RS
Measure of ADHD symptoms
Measured: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits
CAARS
Measure of ADHD symptoms
Measured: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits
CGI-BP
Measured: Baseline (Week 0) to Endpoint (Week 4); Completed weekly on all 6 visits
Q-LES-Q
Quality of Life
Measured: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits
AAQoL
Quality of Life
Measured: Baseline (Week 0), Week 2, Endpoint (Week 4); Completed on 3 visits
Metabolic Peptidergic systems
Insulin; Resistin; Ghrelin; Leptin; Adiponectin
Measured: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263548
- Sponsor's protocol ID
- Vyvanse-BD
- Status last verified
- May 2012
- First submitted
- 14 Dec 2010
- Last updated
- 1 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder
- ClinicalTrials.gov ID
- NCT01263548
- Acronym / sponsor ID
- Vyvanse-BD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ADHD in the adult population is associated with several measures of harmful dysfunction. For example, adult ADHD is associated with high rates of separation/divorce and never-married status, lower educational attainment and occupational achievement, absenteeism, presenteeism, and job termination, as well as decreased social function. Individuals with adult ADHD are more likely than controls to have a comorbid diagnosis of bipolar disorder, alcohol and substance abuse, as well as antisocial personality disorder.
Psychostimulants are the most frequently employed medications in the treatment of adult ADHD. Several psychostimulants are Health Canada and US FDA-approved for the treatment of ADHD symptoms in adulthood.
Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the treatment of ADHD symptomatology in adult individuals with bipolar disorder.
Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric) ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion, lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a longer duration of effect consistent throughout the day with reduced potential for risk of abuse. Vyvanse is generally well tolerated with an adverse event profile similar to other psychostimulant medications. Available evidence indicates that in most treated subjects, Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some individuals, it is associated with improvement in both glucose and lipid homeostasis.
The evaluation of safety/tolerability profiles as well as the effectiveness of lisdexamfetamine in a "real-world" population has significant translational value.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vyvanse | – | Drug: lisdexamfetamine dimesylateThis is an open-label study which means that all study participants will be taking active study medication, Vyvanse. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals who have a diagnosis of Bipolar Disorder and ADHD.
Key inclusion criteria (7 listed)
- Outpatient status
- Male or female subjects between the ages of 18 to 55 years, inclusive
- Primary diagnosis of Bipolar Disorder and ADHD according to criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) using the Mini International Neuropsychiatric Interview.
- Agree to use reliable method of birth control
- YMRS score </= 12
Key exclusion criteria (12 listed)
- Current Axis I primary psychiatric diagnosis other than Bipolar Disorder and ADHD
- Current Axis II psychiatric disorder of primary clinical focus
- Active alcohol as well as illicit or other substance abuse during the past 3 months
- Current clinically unstable medical condition.
- Inability to understand and engage in the process of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lisdexamfetamine dimesylateAlso: VyvanseDosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks | Drug | Vyvanse |
Primary outcome
Metabolic parameters
Time frame: Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits
Weight; BMI; Waist circumference
6 secondary outcomes
ADHD-RS
Time frame: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits
CAARS
Time frame: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits
CGI-BP
Time frame: Baseline (Week 0) to Endpoint (Week 4); Completed weekly on all 6 visits
Q-LES-Q
Time frame: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits
AAQoL
Time frame: Baseline (Week 0), Week 2, Endpoint (Week 4); Completed on 3 visits
Metabolic Peptidergic systems
Time frame: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
Related trials for Attention Deficit/Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit/Hyperactivity Disorder and Bipolar Disorder, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic parameters (time frame: Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.