Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity
Information source: Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders
Intervention: Lisdexamfetamine Dimesylate (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada Official(s) and/or principal investigator(s): Stephen Collins, MBChB, FRCPC, Principal Investigator, Affiliation: McMaster University
Overall contact: Beth Patterson, BScN, RN, BEd, Phone: 1-289-396-4242, Email: beth@anxietyaddtreatment.com
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.
Clinical Details
Official title: Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: ADHD Rating ScaleClinical Global Impression - Improvement Scale (CGI-I)
Secondary outcome: Yale Global Tic Severity Scale (YGTSS)the Overall Anxiety Severity and Impairment Scale (OASIS) The Weiss Functional Impairment Rating Scale-Self Report (WFIRS-S) Barkley Adult ADHD Rating Scale--IV(BAARS-IV) Revised Padua Inventory The Panic and Agoraphobia Scale (PAS) Quick Inventory of Depressive Symptoms (QID-SR-16) The Sheehan Disability Scale (SDS) GAD-7 Social Phobia Inventory (SPIN) The Life Events Questionnaire (LEQ) The Pittsburgh Sleep Quality Index (PSQI) Clinical Global Impression - Severity (CGI-S)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
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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.
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Locations and Contacts
Beth Patterson, BScN, RN, BEd, Phone: 1-289-396-4242, Email: beth@anxietyaddtreatment.com
Centre for Anxiety, Attention Deficit and Trauma, Hamilton, Ontario L8S 1B7, Canada; Recruiting Beth Patterson, BScN, RN, BEd, Phone: 289-396-4242, Email: beth@anxietyaddtreatment.com Stephen Collins, MBChB, Principal Investigator Michael Van Ameringen, MD, FRCPC, Sub-Investigator
Additional Information
Starting date: April 2013
Last updated: February 3, 2015
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