Venlafaxine for Depression in Alzheimer's Disease (DIADs-3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Paul B. Rosenberg, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01609348
First received: April 27, 2012
Last updated: September 17, 2013
Last verified: September 2013

April 27, 2012
September 17, 2013
April 2012
December 2013   (final data collection date for primary outcome measure)
225 mg daily dose of venlafaxine over 12 weeks will produce changes in response on the modified AD Cooperative Study-Clinical Global Impression of Change and the Cornell Scale for Depression in Dementia. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Treatment will be considered efficacious if the proportion of worse categories is lower under treatment than under control on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change and improvements on the Cornell Scale for Depression in Dementia.
Same as current
Complete list of historical versions of study NCT01609348 on ClinicalTrials.gov Archive Site
Examine in a proof of concept, 12-week randomized controlled trial, the safety of venlafaxine at a target dose of 225 mg daily for the treatment of Depression in patients with AD. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Proportions of individuals in each treatment group with adverse events and serious adverse events will be compared using logistic regression.
Same as current
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Venlafaxine for Depression in Alzheimer's Disease (DIADs-3)
Venlafaxine for Depression in Alzheimer's Disease

This study will test the use of venlafaxine to treat the depression in Alzheimer's Disease. Venlafaxine works by increasing natural substances in the brain (serotonin and norepinephrine) that help maintain mental balance. Alzheimer's disease (AD) is the commonest neurodegenerative disease of aging and the cause of major financial and emotional burden to patients, families and caregivers, and society. Depression is a very common symptom of AD, affecting as many as 50% of patients over their illness. Depression in AD (Alzheimer's disease) contributes greatly to patient disability and caregiver distress. Neither psychosocial interventions nor psychotropic medications have proven effective to date for the treatment of depression in AD.Venlafaxine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depression but it is not known whether or not it can help depression in Alzheimer's Disease.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Depression
  • Drug: Placebo
    Capsule matching active drug to be taken once a day for 12 weeks
  • Drug: Venlafaxine
    225 mg daily for 12 weeks
  • Active Comparator: Venlafaxine
    225 mg daily over 12 weeks
    Intervention: Drug: Venlafaxine
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dementia due to Alzheimer's disease by DSM-IV (TR) criteria (90), with a Mini-Mental State Exam (MMSE) (82) score of 10-26 inclusive;
  • dAD as defined by the NIMH(National Institute of Mental Health) Consensus Criteria,
  • Clinical Dementia Rating Scale of 1 "mild" or 2 "moderate". Ratings of 3 "severe" will be excluded because many of the instruments lack validity in the presence of severe cognitive impairment, particularly language deficits.
  • Sufficiently good health to be treated using the study protocol in usual care circumstances;
  • Patient or surrogate and caregiver provides informed consent for participation in the study;
  • A caregiver is available who spends at least 10 hours per week with the patient, supervises her care, and is willing to accompany the patient to study visits and to provide information about the patient.
  • Female participants must be at least 2 years post menopause or surgically sterilized. Exclusion Criteria
  • Presence of a brain disease that might otherwise fully explain the presence of dementia, such as stroke, Parkinson's disease, traumatic brain injury, multiple sclerosis, and similar neurologic diseases;
  • Clinically significant psychosis that requires antipsychotic treatment; -Treatment with venlafaxine is contraindicated in the opinion of the attending psychiatrist, for example if there is a prior history of dangerous or -unacceptable side effects when treated with venlafaxine;
  • Failure of treatment with venlafaxine in the past for depression after convincing evidence of a "good trial," for example 8 weeks at the highest tolerated dose;
  • Treatment for a condition or with a medication that would prohibit the safe concurrent use of venlafaxine (specifically including systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg);
  • Diagnosis of congenital long Q-T syndrome
  • The patient requires psychiatric hospitalization for depression or is suicidal;
  • Initiation, discontinuation or dose changes in cholinesterase inhibitor or memantine use within the 4 weeks prior to screening.
Both
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No
Contact: Jane Pollutra, R.N. 410-550-4258 jpollut1@jhmi.edu
Contact: Julia Pedroso, R.N. 410-550-9054 jpedroso@jhmi.edu
United States
 
NCT01609348
DIADs-3
No
Paul B. Rosenberg, Johns Hopkins University
Johns Hopkins University
Not Provided
Not Provided
Johns Hopkins University
September 2013

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