Status:
COMPLETED
Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder.
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Shire
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study aims to test the effect of a newly-approved stimulant medication, lisdexamfetamine dimesylate (Vyvanse), on specific residual symptoms of depression found in some patients who are undergoin...
Detailed Description
This protocol is designed to test the hypothesis that a cluster of co-occurring residual symptoms sometimes found in treated depression will respond as a group to psychostimulant therapy. This cluster...
Eligibility Criteria
Inclusion
- Meeting diagnostic criteria for major depression during the present episode of illness, currently with at least mild improvement by report (CGI-I ≥3) but with continuing residual symptoms.
- A score of ≥10 on MADRS items 1,2,6,7 and 8, (the MADRS Dysphoric Apathy/Retardation factor, Parker et al., 2003) at screening and randomization. These 5 items are: Apparent sadness, Reported sadness, Concentration difficulties, Lassitude, and Inability to feel. A score of ≥3 will be required for at least 2 of these items.
- A score of 3 or 4 on the Clinical Global Impression of Severity (CGI-S) at screening and randomization.
- At randomization subjects must have received therapeutic dosages of approved SSRI or SNRI agents for at least 8 weeks, with the last 4 weeks at a constant dosage.
- Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (B-hCG) pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit, and agree to use one of the following methods of birth control: oral contraceptives, contraceptive implants, injectable contraceptives, IUDs, double-barrier contraception, sexual abstinence or vasectomized partner(s).
Exclusion
- Treatment within 4 weeks of randomization with any non-SSRI/SNRI antidepressant (trazodone is permitted up to 100 mg at night for sleep); any antipsychotic agent; any mood stabilizer; any standing benzodiazepine regimen other than at low doses for sleep (≤ 1 mg lorazepam HS or the equivalent); or a standing regimen of any other agent that may affect cognitive function (e.g., psychostimulants, including modafinil or R-modafinil).
- Any current or past psychotic disorder, Bipolar I or II disorder, Current panic disorder, History of ADHD, Antisocial Personality Disorder or Borderline Personality Disorder, Mental retardation or any dementing disorder.
- Covi Anxiety Scale score greater than Raskin Depression Scale score at Screening, to exclude subjects with more prominent anxiety than depression
- MADRS Sleep (item 4), or Appetite (item 5) \>3 at screening or randomization
- Initial insomnia at screening that is not adequately controlled by sleep medication (trazodone up to 100 mg HS for sleep and/or ≤ 1 mg lorazepam HS or the equivalent).
- Medical conditions that might be exacerbated by Vyvanse treatment, such as uncontrolled hypertension or angina; or conditions that would make study findings hard to interpret, such as hyperthyroidism
- History of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
- Known cardiac structural abnormality or any other condition that may affect cardiac performance
- Any clinically significant ECG or laboratory abnormality at Screening
- Current abnormal thyroid function, as defined by abnormal TSH at Screening (Treatment with a stable dose of thyroid medication for at least 3 months is permitted if TSH is normal at screening).
- Suicide attempt within the past 2 years or a history of any homicidal behavior.
- MADRS Suicidal thoughts (item 10) \>4 at any study visit, or if a patient is considered by the investigator to be at clinical risk of suicide at any time in the course of the study.
- resting sitting systolic blood pressure \>149mmHg or diastolic blood pressure \> 95mmHg. Subjects may be on monotherapy with anti-hypertensive medication.
- documented allergy, hypersensitivity, intolerance, or non-responsivity to methylphenidate or amphetamines.
- Subject has a history of a substance use disorder (abuse or dependence, as defined by DSM-IV-TR™), with the exception of nicotine dependence, within 6 months prior to screening.
- Subject has glaucoma
- Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01148979
Start Date
September 1 2010
End Date
October 1 2014
Last Update
May 23 2017
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478