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Venlafaxine for Depression in Alzheimer's Disease (DIADs-3) | Clinical Trials | Clareo Health

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

Venlafaxine for Depression in Alzheimer's Disease

NCT01609348•Johns Hopkins University

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Dementia due to Alzheimer's disease by Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-IV (TR) criteria (90), with a Mini-Mental State Exam (MMSE) (82) score of 10-26 inclusive;
•Depression as defined by the National Institute of Mental Health (NIMH) 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.

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 (2)

Johns Hopkins at Bayview

Baltimore, Maryland, United States

Reading Hospital

West Reading, Pennsylvania, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

December 1, 2016

Completion Date

January 1, 2017

Last Updated

January 31, 2018

Enrollment

ACTUAL participants

Conditions

Alzheimer's DiseaseDepression

Interventions

Placebo

DRUG

Venlafaxine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

Readiness and Progress in Emotion Regulation Therapy

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease