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Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive DisordersPhase 4NCT01863459

Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity

A Phase 4 study testing Lisdexamfetamine Dimesylate in people with Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders, run by Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. To evaluate the safety, and efficacy of Lisdexamfetamine dimesylate in the treatment of outpatients with DSM-IV ADHD with anxiety and depressive disorder comorbidity, as well as to evaluate the effects on quality of life . 2. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Lisdexamfetamine Dimesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteCanada
Study dates
Apr 2013to Mar 2017
Phase
Phase 4
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Outpatient men and woman aged 18 to 65 years.
  • Patients with a DSM-IV diagnosis of ADHD according to the MINI-Plus, with an ADHD-RS score ≥ 24 and at least one of the following comorbid psychiatric disorders: SP, PDAG, OCD, GAD, MDD or Dysthymia.
  • Patients who qualify for comorbid DSM-IV major depressive disorder - current episode, will be allowed into the study provided that they have a baseline Montgomery Asberg Depression Rating Scale (MADRS) score of less than or equal to 25.
  • The ability to comprehend and satisfactorily comply with protocol requirements.
  • 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.
  • -

Who cannot join

  • Patients who currently fulfill criteria for a lifetime history of bipolar disorder, history of drug abuse, a history of schizophrenia or other psychotic disorders, delirium, dementia and amnesic and other cognitive disorders, or are in a current agitated state.
  • Patients with a concurrent AXIS-II, cluster A personality disorder or borderline or antisocial personality disorder.
  • Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviours within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
  • Patients receiving current psychotherapy, including cognitive behavioural therapy for either ADHD or an anxiety or mood disorder, within 4 weeks prior to the baseline period.
  • Patients who, during the course of the study would be likely to require treatment with a prohibited concomitant therapy (please refer to Concomitant Medication section below).
  • Patients who are known to be allergic to amphetamines or components of Lisdexamfetamine dimesylate, have known hypersensitivity or idiosyncrasy to Lisdexamfetamine dimesylate or sympathomimetic amines.
Show all 23Show fewer
  • Patients with a current seizure disorder, organic brain disorder or history of seizure disorder (except for febrile seizures in childhood).
  • Patients who have thyroid pathology, treatment of which has not been stabilized for at least 3 months.
  • MAO inhibitors within 3 weeks of the start of the baseline.
  • Current use of bupropion or tri-cyclic antidepressants, with the exception of clomipramine.
  • Current use of clonidine, modafinil or atomoxetine.
  • Previous intolerance or failure to respond to an adequate trial of Lisdexamfetamine dimesylate (defined as a minimum of 30mg per day for at least 4 weeks).
  • Current use of any psycho-stimulant, and greater than 2 failed trials using adequate doses of a methylphenidate-based or amphetamine agent.
  • Pregnant or lactating females or if sexually active and of childbearing potential not using adequate methods of birth control. If a subject becomes pregnant during the study she will be discontinued immediately and followed appropriately (at minimum, until the outcome of the pregnancy is determined).
  • Patients who have a history or evidence of a medical condition that would expose them to an increase or significant adverse event or interfere with assessments of safety and efficacy during the course of the trial including: advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, or other pre-existing cardiac abnormalities or other serious cardiac problems.
  • Patients with a history of Glaucoma.
  • Sleep medications during the study period are excluded with the exception of zopiclone and over-the-counter sleep aids.
  • Patients using any herbal psychoactive treatments, eg; St.John's Wort, Valerian, Kava Kava, or Chamomile Extract within 14 days prior to randomization.
  • Patients who have received electroconvulsive therapy within the previous 6 months.
  • Patients with any condition or on any therapy that in the investigator's opinion or as indicated in the Lisdexamfetamine dimesylate product label, that may pose a risk to the subject or interfere with the study objective.
  • Patients having clinically significant abnormal laboratory or ECG findings not resolved by the baseline examination.
  • The exclusion criteria must continue to be satisfied in order for the patient to enter the randomization phase at the end of the baseline.
  • -

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Anxiety, Attention Deficit and Trauma

    Hamilton, Ontario, L8S 1B7

Other trials in Canada

About this study

  1. To evaluate the safety, and efficacy of Lisdexamfetamine dimesylate in the treatment of outpatients with DSM-IV ADHD with anxiety and depressive disorder comorbidity, as well as to evaluate the effects on quality of life .
  2. To evaluate the efficacy of Lisdexamfetamine dimesylate in the treatment of anxiety and depressive disorders which commonly occur with ADHD.
  3. To examine the potential relationship between telomere length and Adult ADHD with comorbidity and the potential effect of treatment response.
  4. To examine the potential associations with specific genes and Adult ADHD.
Being tested
Lisdexamfetamine Dimesylate, placebo
Keywords
ADHD, ADD, Anxiety, Anxiety Disorders, Depression, Attention, Attention Deficit
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Depressive Disorder, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lisdexamfetamine DimesylateDrug

    Also called Vyvanse

  • placeboDrug

Study groups in NCT01863459
Study groupRoleWhat they receive
Lidexamfetamine DimesylateExperimentalLisdexamfetamine 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
Receives: Drug: Lisdexamfetamine Dimesylate
PlaceboPlacebo comparatorPlacebo will be dosed in the same fashion as the active intervention - 3 potential dose levels. Placebo is taken once per day for 8 weeks
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ADHD Rating Scale

    Measured: Change from Baseline to Week 18

  2. Clinical Global Impression - Improvement Scale (CGI-I)

    Measured: Change from Week 1 to Week 18

Secondary outcomes (13)

  1. Yale Global Tic Severity Scale (YGTSS)

    Measured: Change from Baseline to Week 18

  2. the Overall Anxiety Severity and Impairment Scale (OASIS)

    Measured: Change from Baseline to Week 18

  3. The Weiss Functional Impairment Rating Scale-Self Report (WFIRS-S)

    Measured: Change from Baseline to Week 18

  4. Barkley Adult ADHD Rating Scale--IV(BAARS-IV)

    Measured: Change from Baseline to Week 18

  5. Revised Padua Inventory

    Measured: Change from Baseline to Week 18

  6. The Panic and Agoraphobia Scale (PAS)

    Measured: Change from Baseline to Week 18

  7. Quick Inventory of Depressive Symptoms (QID-SR-16)

    Measured: Change from Baseline to Week 18

  8. The Sheehan Disability Scale (SDS)

    Measured: Change from Baseline to Week 18

  9. GAD-7

    Measured: Change from Baseline to Week 18

  10. Social Phobia Inventory (SPIN)

    Measured: Change from Baseline to Week 18

  11. The Life Events Questionnaire (LEQ)

    Measured: Visit 2 (Week: Baseline)

  12. The Pittsburgh Sleep Quality Index (PSQI)

    Measured: Change from Baseline to Week 18

  13. Clinical Global Impression - Severity (CGI-S)

    Measured: Change from Baseline to Week 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01863459
Sponsor's protocol ID
LDX-COMORB-1
Status last verified
Aug 2017
First submitted
17 May 2013
Last updated
2 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lisdexamfetamine Dimesylate in people with Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders, run by Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada 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 8 inclusion and 23 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 2 Aug 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

ADHD Rating Scale (time frame: Change from Baseline to Week 18). The study lists 2 primary outcomes in all. 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 NCT01863459.

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 2 Aug 2017.

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