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

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ClinicalTrials.gov Identifier: NCT01609348
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Depression Drug: Placebo Drug: Venlafaxine Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Venlafaxine for Depression in Alzheimer's Disease
Study Start Date : April 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change. [ Time Frame: 12 weeks ]

    Treatment will be considered efficacious if the proportion of worse categories (including 'minimal worsening', 'moderate worsening', or 'marked worsening') is lower under treatment than control on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change.

    Clinical Global Impression of Change: This is a 7-item score ranging from "markedly worse" to "markedly improved". It is assessed by the study clinician who interviews both participant and informant and makes an informed judgment how to incorporate their input




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609348


Locations
United States, Maryland
Johns Hopkins at Bayview
Baltimore, Maryland, United States, 21225
United States, Pennsylvania
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Sponsors and Collaborators
Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01609348     History of Changes
Other Study ID Numbers: NA_00066043
First Posted: June 1, 2012    Key Record Dates
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Alzheimer Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs