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

NCT01863459 | Completed Phase 4

• 1 other identifier: LDX-COMORB-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate the efficacy of Lisdexamfetamine dimesylate in the treatment of anxiety and depressive disorders which commonly occur with ADHD.
3. 3.To examine the potential relationship between telomere length and Adult ADHD with comorbidity and the potential effect of treatment response.
4. 4.To examine the potential associations with specific genes and Adult ADHD.

Conditions

Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders

Keywords

ADHD; ADD; Anxiety; Anxiety Disorders; Depression; Attention; Attention Deficit

Outcome Measures

Primary Outcomes (2)

• ADHD Rating Scale

  Change from Baseline to Week 18

• Clinical Global Impression - Improvement Scale (CGI-I)

  Change from Week 1 to Week 18

Secondary Outcomes (13)

• Yale Global Tic Severity Scale (YGTSS)

  Change from Baseline to Week 18

• the Overall Anxiety Severity and Impairment Scale (OASIS)

  Change from Baseline to Week 18

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

  Change from Baseline to Week 18

• Barkley Adult ADHD Rating Scale--IV(BAARS-IV)

  Change from Baseline to Week 18

• Revised Padua Inventory

  Change from Baseline to Week 18

Study Arms (2)

Lidexamfetamine Dimesylate

EXPERIMENTAL

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

Drug: Lisdexamfetamine Dimesylate

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Lisdexamfetamine Dimesylate DRUG

Also known as: Vyvanse

Lidexamfetamine Dimesylate

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Written informed consent given prior to entering the baseline period of the study.
• \. 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.
• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada: lead
• Shire: collaborator

Study Sites (1)

Centre for Anxiety, Attention Deficit and Trauma

Hamilton, Ontario, L8S 1B7, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Depressive Disorder; Anxiety Disorders; Depression

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Stephen Collins, MBChB, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 29, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

CA (1)