Depression in Alzheimer's Disease-2

NCT00086138 | Completed Phase 2 Results DMC

• 2 other identifiers: U01MH066136DATR A4-GPX
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Alzheimer's Disease; Depression

Keywords

Alzheimer's disease; Depression

Outcome Measures

Primary Outcomes (1)

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

  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".

  Measured at Week 12

Secondary Outcomes (1)

• Remission According to Cornell Scale for Depression in Dementia Scale

  Measured at Weeks 12

Study Arms (2)

1

EXPERIMENTAL

Participants will receive sertraline at a target dose of 100mg daily.

Drug: Sertraline (Zoloft)

2

PLACEBO COMPARATOR

Participants will receive placebo matched to sertraline

Drug: Placebo

Interventions

Sertraline (Zoloft) DRUG

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

1

Placebo DRUG

Placebo designed to mimic sertraline taken daily for 24 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

North Charleston, South Carolina, 29406, United States

Location

Related Publications (3)

• Rosenberg PB, Drye LT, Martin BK, Frangakis C, Mintzer JE, Weintraub D, Porsteinsson AP, Schneider LS, Rabins PV, Munro CA, Meinert CL, Lyketsos CG; DIADS-2 Research Group. Sertraline for the treatment of depression in Alzheimer disease. Am J Geriatr Psychiatry. 2010 Feb;18(2):136-45. doi: 10.1097/JGP.0b013e3181c796eb.

  PMID: 20087081 RESULT

• Drye LT, Martin BK, Frangakis CE, Meinert CL, Mintzer JE, Munro CA, Porsteinsson AP, Rabins PV, Rosenberg PB, Schneider LS, Weintraub D, Lyketsos CG; DIADS-2 Research Group. Do treatment effects vary among differing baseline depression criteria in depression in Alzheimer's disease study +/- 2 (DIADS-2)? Int J Geriatr Psychiatry. 2011 Jun;26(6):573-83. doi: 10.1002/gps.2565.

  PMID: 20672243 DERIVED

• Martin BK, Frangakis CE, Rosenberg PB, Mintzer JE, Katz IR, Porsteinsson AP, Schneider LS, Rabins PV, Munro CA, Meinert CL, Niederehe G, Lyketsos CG. Design of Depression in Alzheimer's Disease Study-2. Am J Geriatr Psychiatry. 2006 Nov;14(11):920-30. doi: 10.1097/01.JGP.0000240977.71305.ee.

  PMID: 17068314 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Paul Rosenberg
• Organization: JHU

prosenb9@jhmi.edu

410-550-9883

Study Officials

• Constantine G. Lyketsos, MD, MHS

  Johns Hopkins University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Bayview Psychiatry

Study Record Dates

• First Submitted: June 25, 2004
• First Posted: June 28, 2004
• Study Start: July 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2009
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Locations

US (5)