Alzheimer's DiseasePhase 2/3DIADS-2NCT00086138
Depression in Alzheimer's Disease-2
A Phase 2/3 study testing Sertraline (Zoloft) in people with Alzheimer's Disease and Depression, run by Johns Hopkins University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease, Depression
- What is being tested?
- Sertraline (Zoloft)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2004to Jul 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Southern California
Los Angeles, California, 90033
Medical University of South Carolina
North Charleston, South Carolina, 29406
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Rochester
Rochester, New York, 14620
About this study
Official title: Depression in Alzheimer's Disease (DIADS-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.
Read the detailed description
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.
- Conditions
- Alzheimer's Disease, Depression
- Being tested
- Sertraline (Zoloft), Placebo
- Keywords
- Alzheimer's disease, Depression
- Medical subject headings
- Alzheimer Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline (Zoloft)Drug
Sertraline: range of 25 to 125 mg per day for 24 weeks
PlaceboDrug
Placebo designed to mimic sertraline taken daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive sertraline at a target dose of 100mg daily. Receives: Drug: Sertraline (Zoloft) |
| 2 | Placebo comparator | Participants will receive placebo matched to sertraline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Week 12
Secondary outcomes (1)
Remission According to Cornell Scale for Depression in Dementia Scale
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.
Measured: Measured at Weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2004 (estimated)
- Study startJul 2004
- Primary completionJul 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Constantine G. Lyketsos, Johns Hopkins University
- Investigators
- Constantine G. Lyketsos, MD, MHS, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086138
- Sponsor's protocol ID
- U01MH066136
- Other IDs
- U01MH066136, DATR A4-GPX
- Acronym
- DIADS-2
- Status last verified
- Feb 2017
- First submitted
- 25 Jun 2004
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20087081Drye 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.
PubMed 20672243Martin 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.
PubMed 17068314
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression in Alzheimer's Disease (DIADS-2)
- ClinicalTrials.gov ID
- NCT00086138
- Acronym / sponsor ID
- DIADS-2 / U01MH066136
- Conditions
- Alzheimer's Disease, Depression
- Keywords
- Alzheimer's disease, Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Jun 2004 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sertraline (Zoloft)Participants will receive sertraline at a target dose of 100mg daily. |
| 2 | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to sertraline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sertraline (Zoloft)Sertraline: range of 25 to 125 mg per day for 24 weeks | Drug | 1 |
| PlaceboPlacebo designed to mimic sertraline taken daily for 24 weeks | Drug | 2 |
Primary outcome
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".
1 secondary outcome
Remission According to Cornell Scale for Depression in Dementia Scale
Time frame: Measured at Weeks 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20087081Rosenberg 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.
- Derived from this study: PubMed 20672243Drye 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.
- Derived from this study: PubMed 17068314Martin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantine G. Lyketsos, MD, MHS study chair
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sertraline (Zoloft) in people with Alzheimer's Disease and Depression, run by Johns Hopkins University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC) (time frame: Measured at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00086138, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.