Trial · NCT02960763

Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

NCT02960763, Phase 4, Completed, Washington University School of Medicine; results first posted 2022-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Optimizing Outcomes of Treatment-Resistant Depression in Older Adults. Trials, record NCT02960763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02960763

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
NCT number: NCT02960763
Status: Completed
Phases: Phase 4
Enrollment: 742 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Treatment Resistant Depression, Major Depressive Disorder, Treatment-Refractory Depression, Late Life Depression, Geriatric Depression
Interventions: Aripiprazole Augmentation, Bupropion Augmentation, Switch to bupropion, Lithium Augmentation, Switch to nortriptyline
First posted: 2016-11-10
Last updated: 2024-10-03
Results first posted: 2022-05-24

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Psychological Well-Being	Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks	Psychological well-being was assessed using the NIH Toolbox Psychological Wellbeing subscales of Positive Affect and General Life Satisfaction, with a T score calculated as the average of these two subscales. Higher scores indicate greater positive affect and life satisfaction. Reference T-score (mean=50, SD=10).
Primary	Number of Participants With Remission From Depression	Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks	Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms.
Primary	Serious Adverse Events	Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks	Life threatening illness, hospitalization, or need of medical care.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Psychological Well-Being	Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks	t-score	MEAN
PRIMARY	Number of Participants With Remission From Depression	Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Serious Adverse Events	Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Psychological Well-Being	Aripiprazole Augmentation	baseline	34.7	95% Confidence Interval 33.8 to 35.6	t-score
Psychological Well-Being	Bupropion Augmentation	baseline	35.0	95% Confidence Interval 34.1 to 36.0	t-score
Psychological Well-Being	Switch to Bupropion	baseline	34.8	95% Confidence Interval 33.8 to 35.7	t-score
Psychological Well-Being	Lithium Augmentation	baseline	33.1	95% Confidence Interval 31.9 to 34.4	t-score
Psychological Well-Being	Switch to Nortriptyline	baseline	34.2	95% Confidence Interval 32.9 to 35.4	t-score
Psychological Well-Being	Aripiprazole Augmentation	10 weeks	38.8	95% Confidence Interval 37.9 to 39.8	t-score
Psychological Well-Being	Bupropion Augmentation	10 weeks	38.7	95% Confidence Interval 37.8 to 39.7	t-score
Psychological Well-Being	Switch to Bupropion	10 weeks	36.1	95% Confidence Interval 35.1 to 37.2	t-score
Psychological Well-Being	Lithium Augmentation	10 weeks	35.7	95% Confidence Interval 34.4 to 37.1	t-score
Psychological Well-Being	Switch to Nortriptyline	10 weeks	35.6	95% Confidence Interval 34.3 to 37.0	t-score

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow40

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Step 1	STARTED	Aripiprazole Augmentation	211
Step 1	STARTED	Bupropion Augmentation	206
Step 1	STARTED	Switch to Bupropion	202
Step 1	STARTED	Lithium Augmentation	0
Step 1	STARTED	Switch to Nortriptyline	0
Step 1	COMPLETED	Aripiprazole Augmentation	192
Step 1	COMPLETED	Bupropion Augmentation	188
Step 1	COMPLETED	Switch to Bupropion	174
Step 1	COMPLETED	Lithium Augmentation	0
Step 1	COMPLETED	Switch to Nortriptyline	0

1 to 10 of 40Source ClinicalTrials.gov

See all 40 participant flow

Adverse events115

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Akathisia	Psychiatric disorders	Aripiprazole Augmentation	23	211
other	Akathisia	Psychiatric disorders	Bupropion Augmentation	2	206
other	Akathisia	Psychiatric disorders	Switch to Bupropion	5	202
other	Akathisia	Psychiatric disorders	Lithium Augmentation	2	127
other	Akathisia	Psychiatric disorders	Switch to Nortriptyline	0	121
other	Headache	General disorders	Aripiprazole Augmentation	16	211
other	Headache	General disorders	Bupropion Augmentation	17	206
other	Headache	General disorders	Switch to Bupropion	15	202
other	Headache	General disorders	Lithium Augmentation	13	127
other	Headache	General disorders	Switch to Nortriptyline	6	121

1 to 10 of 115Source ClinicalTrials.gov

See all 115 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aripiprazole Augmentation	1	211
Total, all-cause mortality	Bupropion Augmentation	1	206
Total, all-cause mortality	Switch to Bupropion	1	202
Total, all-cause mortality	Lithium Augmentation	0	127
Total, all-cause mortality	Switch to Nortriptyline	0	121
Total, other adverse events	Aripiprazole Augmentation	148	211
Total, other adverse events	Bupropion Augmentation	120	206
Total, other adverse events	Switch to Bupropion	136	202
Total, other adverse events	Lithium Augmentation	93	127
Total, other adverse events	Switch to Nortriptyline	93	121

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36867173	DERIVED	PubMed
38822571	DERIVED	PubMed
41237789	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01MH114966	5/5 Neurocognitive and neuroimaging biomarkers: predicting progression toward dementia in patients with treatment resistant late-life depression	SHIMONY, JOSHUA S	WASHINGTON UNIVERSITY	NATIONAL INSTITUTE OF MENTAL HEALTH	2017 to 2021

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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