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Trial record 13 of 111 for:    nrp 104 OR lisdexamfetamine

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

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ClinicalTrials.gov Identifier: NCT01863459
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada

Tracking Information
First Submitted Date  ICMJE May 17, 2013
First Posted Date  ICMJE May 29, 2013
Last Update Posted Date August 2, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • ADHD Rating Scale [ Time Frame: Change from Baseline to Week 18 ]
  • Clinical Global Impression - Improvement Scale (CGI-I) [ Time Frame: Change from Week 1 to Week 18 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
  • ADHD Rating Scale [ Time Frame: each visit (13 visits over 18 weeks: Screening, Baseline, Weeks 2, 3, 5, 7, 9, 10, 11, 12, 14, 16 and 18) ]
  • Clinical Global Impression - Improvement Scale (CGI-I) [ Time Frame: each visit following Screening (12 visits over 17 weeks, Weeks Baseline, 2, 3, 5, 7, 9, 10, 11, 12, 14, 16 and 18) ]
Change History Complete list of historical versions of study NCT01863459 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Change from Baseline to Week 18 ]
  • the Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Change from Baseline to Week 18 ]
  • The Weiss Functional Impairment Rating Scale-Self Report (WFIRS-S) [ Time Frame: Change from Baseline to Week 18 ]
  • Barkley Adult ADHD Rating Scale--IV(BAARS-IV) [ Time Frame: Change from Baseline to Week 18 ]
  • Revised Padua Inventory [ Time Frame: Change from Baseline to Week 18 ]
  • The Panic and Agoraphobia Scale (PAS) [ Time Frame: Change from Baseline to Week 18 ]
  • Quick Inventory of Depressive Symptoms (QID-SR-16) [ Time Frame: Change from Baseline to Week 18 ]
  • The Sheehan Disability Scale (SDS) [ Time Frame: Change from Baseline to Week 18 ]
  • GAD-7 [ Time Frame: Change from Baseline to Week 18 ]
  • Social Phobia Inventory (SPIN) [ Time Frame: Change from Baseline to Week 18 ]
  • The Life Events Questionnaire (LEQ) [ Time Frame: Visit 2 (Week: Baseline) ]
  • The Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Change from Baseline to Week 18 ]
  • Clinical Global Impression - Severity (CGI-S) [ Time Frame: Change from Baseline to Week 18 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
  • Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Visits 2, 7, 8 and 13 (Weeks: Baseline, 9 and 18) ]
  • the Overall Anxiety Severity and Impairment Scale (OASIS) [ Time Frame: Visits 2, 5, 7, 8, 11 and 13 (Weeks: Baseline, 5, 9, 10, 14 and 18) ]
  • The Weiss Functional Impairment Rating Scale-Self Report (WFIRS-S) [ Time Frame: Visits 2, 7, 8, and 13 (Weeks: Baseline, 9 and 18) ]
  • Barkley Adult ADHD Rating Scale--IV(BAARS-IV) [ Time Frame: each visit (13 visits over 18 weeks: Screening, Baseline, Weeks 2, 3, 5, 7, 9, 10, 11, 12, 14, 16 and 18) ]
  • Revised Padua Inventory [ Time Frame: Visits 2, 5, 7,8,11 and 13 (Weeks: Baseline, 5, 9, 10, 14 and 18) ]
  • The Panic and Agoraphobia Scale (PAS) [ Time Frame: Visits 2, 5, 7, 8, 11 and 13 (Weeks: Baseline, 5, 9, 10, 14 and 18) ]
  • Quick Inventory of Depressive Symptoms (QID-SR-16) [ Time Frame: Visits 2, 5, 7, 8, 11 and 13 (Weeks:Baseline, 5, 9, 10, 14 and 18) ]
  • The Sheehan Disability Scale (SDS) [ Time Frame: Visits 2, 5, 7, 8, 11 and 13 (Weeks: Baseline, 5, 9, 10, 14 and 18) ]
  • GAD-7 [ Time Frame: Visits 2, 5, 7, 8, 11 and 13 (Weeks: Baseline, 5, 9, 10, 14 and 18) ]
  • Social Phobia Inventory (SPIN) [ Time Frame: Visits 2, 5, 7, 8, 11 and 13 (Weeks: Baseline, 5, 9, 10, 14 and 18) ]
  • The Life Events Questionnaire (LEQ) [ Time Frame: Visit 2 (Week: Baseline) ]
  • The Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Visits 2, 7, 8 and 13 (Week: Baseline, 8, 9 and 18) ]
  • Clinical Global Impression - Severity (CGI-S) [ Time Frame: each visit (13 visits over 18 weeks: Screening, Baseline, Weeks 2, 3, 5, 7, 9, 10, 11, 12, 14, 16 and 18) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity
Official Title  ICMJE Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders
Intervention  ICMJE
  • Drug: Lisdexamfetamine Dimesylate
    Other Name: Vyvanse
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: Lidexamfetamine Dimesylate

    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

    Intervention: Drug: Lisdexamfetamine Dimesylate
  • Placebo Comparator: Placebo

    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

    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2016)
42
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2013)
40
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Outpatient men and woman aged 18 to 65 years.
  2. 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.
  3. 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.
  4. 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.

-

Exclusion Criteria:

  1. 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.
  2. Patients with a concurrent AXIS-II, cluster A personality disorder or borderline or antisocial personality disorder.
  3. 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.
  4. 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.
  5. 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).
  6. 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.
  7. Patients with a current seizure disorder, organic brain disorder or history of seizure disorder (except for febrile seizures in childhood).
  8. Patients who have thyroid pathology, treatment of which has not been stabilized for at least 3 months.
  9. MAO inhibitors within 3 weeks of the start of the baseline.
  10. Current use of bupropion or tri-cyclic antidepressants, with the exception of clomipramine.
  11. Current use of clonidine, modafinil or atomoxetine.
  12. 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).
  13. Current use of any psycho-stimulant, and greater than 2 failed trials using adequate doses of a methylphenidate-based or amphetamine agent.
  14. 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).
  15. 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.
  16. Patients with a history of Glaucoma.
  17. Sleep medications during the study period are excluded with the exception of zopiclone and over-the-counter sleep aids.
  18. Patients using any herbal psychoactive treatments, eg; St.John's Wort, Valerian, Kava Kava, or Chamomile Extract within 14 days prior to randomization.
  19. Patients who have received electroconvulsive therapy within the previous 6 months.
  20. 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.
  21. 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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01863459
Other Study ID Numbers  ICMJE LDX-COMORB-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada
Study Sponsor  ICMJE Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada
Collaborators  ICMJE Shire
Investigators  ICMJE
Principal Investigator: Stephen Collins, MBChB, FRCPC McMaster University
PRS Account Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP