Attention Deficit Disorder With HyperactivityPhase 2NCT00940693
Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)
A Phase 2 study testing duloxetine in people with Attention Deficit Disorder With Hyperactivity, run by Université de Montréal at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of ADHD of at least moderate intensity
- Able to give consent
- Able to swallow capsules
Who cannot join
- Allergic or do not tolerate duloxetine
- Under psychotherapy for ADHD
- Taking a medication that interacts with duloxetine, including all psychotropic medication
- Treated with medication for ADHD
- Unstable medical condition
- Severe renal insufficiency
Show all 12Show fewer
- Liver insufficiency
- Substance/alcool abuse or dependency in the last 6 months
- Pregnancy, nursing or inadequate contraceptive methods
- Suicide or homicide risk
- Organic brain syndrome
- Any diagnosis of lifetime bipolar disorder or psychotic disorder, and any actual diagnosis of anxious disorder or major depressive disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
About this study
Official title: Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.
The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults.
- Being tested
- duloxetine, placebo
- Keywords
- Attention Deficit Disorder with Hyperactivity, Duloxetine, Adult, ADDH, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called cymbalta
60 mg capsule once per day for 6 weeks
placeboDrug
one capsule of placebo taken one a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| duloxetine | Active comparator | Not described Receives: Drug: duloxetine |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects.
Measured: baseline and week 6
Secondary outcomes (5)
Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults
Measured: baseline and week 6
Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report : Long Version(44) (CAARS-S:L), in adult ADHD subjects.
Measured: baseline and week 6
Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.
Measured: baseline and week 6
Impact of duloxetine on Quality of life in adults with ADHD
Measured: baseline and week 6
Impact of duloxetine on executive functions and cognitive performances in adults with ADHD
Measured: baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Investigators
- Valérie Tourjman, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940693
- Sponsor's protocol ID
- 09.008
- Status last verified
- Dec 2010
- First submitted
- 15 Jul 2009
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Tourjman SV, Bilodeau M. Improvement with duloxetine in an adult ADHD patient. J Atten Disord. 2009 Jul;13(1):95-6. doi: 10.1177/1087054708326109. Epub 2009 Apr 9.
PubMed 19359667
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Efficacy of Duloxetine in Treating Adults With Attention Deficit Hyperactivity Disorder: a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT00940693
- Acronym / sponsor ID
- 09.008
- Keywords
- Attention Deficit Disorder with Hyperactivity, Duloxetine, Adult, ADDH, ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jul 2009 (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.
The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| duloxetine | Active comparator | Drug: duloxetine |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of ADHD of at least moderate intensity
- Able to give consent
- Able to swallow capsules
Key exclusion criteria (12 listed)
- Allergic or do not tolerate duloxetine
- Under psychotherapy for ADHD
- Taking a medication that interacts with duloxetine, including all psychotropic medication
- Treated with medication for ADHD
- Unstable medical condition
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 |
|---|---|---|
| duloxetineAlso: cymbalta60 mg capsule once per day for 6 weeks | Drug | duloxetine |
| placeboone capsule of placebo taken one a day for 6 weeks | Drug | placebo |
Primary outcome
Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects.
Time frame: baseline and week 6
5 secondary outcomes
Impact of duloxetine on the Clinical Global Impression Scale in ADHD adults
Time frame: baseline and week 6
Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Self Report : Long Version(44) (CAARS-S:L), in adult ADHD subjects.
Time frame: baseline and week 6
Impact of duloxetine on anxious and depressive symptoms in adult ADHD subjects.
Time frame: baseline and week 6
Impact of duloxetine on Quality of life in adults with ADHD
Time frame: baseline and week 6
Impact of duloxetine on executive functions and cognitive performances in adults with ADHD
Time frame: baseline and week 6
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 14 Dec 2010.
- Background: PubMed 19359667Tourjman SV, Bilodeau M. Improvement with duloxetine in an adult ADHD patient. J Atten Disord. 2009 Jul;13(1):95-6. doi: 10.1177/1087054708326109. Epub 2009 Apr 9.
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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.
Valérie Tourjman, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing duloxetine in people with Attention Deficit Disorder With Hyperactivity, run by Université de Montréal 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 3 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 14 Dec 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Impact of duloxetine on the Conners' Adult attention-Deficit/Hyperactivity Disorder Rating Scale-Observer Report:Screening Version (CAARS-O:SV) in adult ADHD subjects. (time frame: baseline and week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00940693, which also lists 1 linked publication.
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 14 Dec 2010.