Completed
DIADS-2

Depression in Alzheimer's Disease (DIADS-2)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Sertraline (Zoloft)

+ Placebo
Drug
Who is being recruted

Alzheimer Disease
+10

+ Mental Disorders
+ Behavioral Symptoms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2 & 3
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleDepression in Alzheimer's Disease (DIADS-2) 
NCT00086138
Principal SponsorJohns Hopkins University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
131 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer Disease
Mental Disorders
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Dementia
Depression
Depressive Disorder
Nervous System Diseases
Neurodegenerative Diseases
Mood Disorders
Neurocognitive Disorders
Tauopathies
Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Participants will receive sertraline at a target dose of 100mg daily.

Sertraline: range of 25 to 125 mg per day for 24 weeks
Group II
Placebo
Participants will receive placebo matched to sertraline

Placebo designed to mimic sertraline taken daily for 24 weeks
Study Objectives
Primary Objectives

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 Objectives

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
Suspended
University of Southern CaliforniaLos Angeles, United StatesSee the location
Suspended
Johns Hopkins HospitalBaltimore, United States
Suspended
University of RochesterRochester, United States
Suspended
University of PennsylvaniaPhiladelphia, United States
Completed5 Study Centers