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OpenTrials
Completed

NCT Number: NCT00086138

Depression in Alzheimer's Disease-2

The purpose of this study is to learn whether treating individuals with Alzheimer's disease and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people with Alzheimer's disease and to their families and caregivers.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Depression Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Southern California, Los Angeles, California, United States

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About this study

Participants are randomly assigned to treatment with sertraline (range 25-125 mg per day) or identical placebo for 24 weeks. There are 8 scheduled in-person visits in the 24 weeks. Visits include neuropsychological testing. Caregivers are asked to are the patient on a Daily Affect Diary for 6 weeks during the study period. Telephone followup is done at weeks 36 and 48. Both groups receive caregiver support/education.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Ability of the participant, caregiver or surrogate to provide written informed consent.
  • Dementia due to Alzheimer's disease
  • Stable treatment for Alzheimer's disease
  • Ability for the participant's caregiver to accompany the participant to study visits and participate in the study.

Exclusion

  • Presence of a brain disease that might otherwise explain the presence of dementia
  • Clinically significant hallucinations or delusions
  • Current treatment of antipsychotics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications
  • Need for hospitalization or residence in a nursing facility

Treatment and study plan

sertraline (Zoloft)

Drug

Sertraline: range of 25 to 125 mg per day for 24 weeks

Placebo

Drug

Placebo designed to mimic sertraline taken daily for 24 weeks

Primary outcomes

  1. Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)

    Time frame: Measured at Week 12

    At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 ("much better") to 7 ("much worse"), with a score of 4 being "no change".

Secondary outcomes

  1. Remission According to Cornell Scale for Depression in Dementia Scale

    Time frame: Measured at Weeks 12

    The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Depression in Alzheimer's Disease (DIADS-2)

Acronym: DIADS-2

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Jun 28, 2004
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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