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

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease; Depression

Intervention: Placebo (Drug); Venlafaxine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Johns Hopkins University

Overall contact:
Jane Pollutra, R.N., Phone: 410-550-4258, Email: jpollut1@jhmi.edu

Summary

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.

Clinical Details

Official title: Venlafaxine for Depression in Alzheimer's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Jane Pollutra, R.N., Phone: 410-550-4258, Email: jpollut1@jhmi.edu

Johns Hopkins at Bayview, Baltimore, Maryland 21225, United States; Recruiting
Jane Pollutra, R.N., Phone: 410-550-4258, Email: jpollut1@jhmi.edu
Sarah Lawrence, M.S., Phone: 410-550-9020, Email: swoody1@jhmi.edu
Paul B. Rosenberg, M.D., Principal Investigator

Reading Hospital, West Reading, Pennsylvania 19611, United States; Recruiting
Elizabeth Hollinger, R.N., Phone: 484-628-8360, Email: Elizabeth.hollinger@readinghealth.org
Kolin Good, M.D., Sub-Investigator

Additional Information

Starting date: April 2012
Last updated: February 10, 2015

Page last updated: August 23, 2015

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