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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
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Depression
Drug: Placebo
Drug: Venlafaxine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Venlafaxine for Depression in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Venlafaxine
225 mg daily over 12 weeks
Drug: Venlafaxine
225 mg daily for 12 weeks
Placebo Comparator: Sugar pill Drug: Placebo
Capsule matching active drug to be taken once a day for 12 weeks

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609348

Contacts
Contact: Jane Pollutra, R.N. 410-550-4258 jpollut1@jhmi.edu
Contact: Julia Pedroso, R.N. 410-550-9054 jpedroso@jhmi.edu

Locations
United States, Maryland
Johns Hopkins at Bayview Recruiting
Baltimore, Maryland, United States, 21225
Contact: Jane Pollutra, R.N.    410-550-4258    jpollut1@jhmi.edu   
Contact: Julia Pedroso, R.N.    410-550-9054    jpedroso@jhmi.edu   
Principal Investigator: Paul B. Rosenberg, M.D.         
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Paul B. Rosenberg, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01609348     History of Changes
Other Study ID Numbers: DIADs-3
Study First Received: April 27, 2012
Last Updated: September 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Depression
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Depression
Depressive Disorder
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014