Optimizing Outcomes of Treatment-Resistant Depression in Older Adults



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:60 - Any
Updated:7/21/2018
Start Date:February 24, 2017
End Date:December 2021
Contact:Emily Lenard, MSW
Email:lenarde@wustl.edu
Phone:314-747-5706

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The purpose of this research study is to assess which antidepressants work the best in older
adults who have treatment-resistant depression (TRD).

Older adult participants with treatment-resistant depression will be randomly assigned to a
Step 1 medication strategy.

- Adding aripiprazole to current antidepressant medication

- Adding bupropion to current antidepressant medication

- Replacing current antidepressant medication with bupropion

If depression is not relieved at the end of 10 weeks, or if participants do not qualify for
Step 1, participants will be randomly assigned to a Step 2 medication strategy:

- Adding lithium to current antidepressant medication

- Replacing current antidepressant medication with nortriptyline

All medication strategies will be offered in collaboration with participants' own physicians
with the the research team providing support and guidance.

After treatment in Step 1 and/or Step 2, participants will enter the Continuation Phase to
assess long term follow-up outcomes for 12 months.

Participants in this clinical trial will also be asked to participate in an additional study
to gather imaging and biomarker data.

Inclusion Criteria:

- Men and women aged 60 and older

- Current Major Depressive Disorder (MDD)

- Failure to respond adequately to two or more antidepressant treatment trials of
recommended dose and length

- Patient Health Questionnaire-9 (PHQ-9) score of 6 or higher

Exclusion Criteria:

- Inability to provide informed consent

- Dementia

- Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective
disorder, schizophreniform disorder, delusional disorder, or current psychotic
symptoms

- High risk for suicide and unable to be managed safely in the clinical trial

- Contraindication to proposed study medications, as determined by study physician
including history of intolerance or non-response to proposed medications.

- Non-correctable, clinically significant sensory impairment interfering with
participation

- Unstable medical illness, including delirium, uncontrolled diabetes mellitus,
hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that
are not under medical management.

- Moderate to severe substance or alcohol use disorder
We found this trial at
5
sites
Saint Louis, Missouri 63110
Principal Investigator: Eric Lenze, MD
Phone: 314-747-5706
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Los Angeles, California 90095
Principal Investigator: Helen Lavretsky, MD
Phone: 310-983-3375
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New York, New York 10032
Principal Investigator: Steven Roose, MD
Phone: 646-774-8666
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Jordan Karp, MD
Phone: 412-246-6006
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1001 Queen Street West
Toronto, Ontario M6J 1H4
Principal Investigator: Benoit Mulsant, MD
Phone: 416-535-8501
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