Treatment Resistant DepressionPhase 4OPTIMUMNCT02960763

Optimizing Outcomes of Treatment-Resistant Depression in Older Adults

A Phase 4 study testing Aripiprazole Augmentation, Bupropion Augmentation and Switch to bupropion in people with Treatment Resistant Depression and Major Depressive Disorder, run by Washington University School of Medicine at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 60 years and older
Conditions the study is for: Treatment Resistant Depression, Major Depressive Disorder, Treatment-Refractory Depression
What is being tested?: Aripiprazole Augmentation, Bupropion Augmentation and Switch to bupropion
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 742 participants
Where: 5 sitesin 2 countries
Study dates: 24 Feb 2017to 1 Sep 2021
Phase: Phase 4
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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 10 or higher

Who cannot join

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

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

UCLA Late-Life Mood, Stress, and Wellness Research Program
Los Angeles, California, 90095
Columbia University Adult and Late Life Depression Clinic
New York, New York, 10032
UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
Pittsburgh, Pennsylvania, 15213
Washington University School of Medicine Healthy Mind Lab
St Louis, Missouri, 63110

Other trials in United States

Canada1 site

Centre for Addiction and Mental Health
Toronto, Ontario, M6J-1H4

Other trials in Canada

About this study

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

Read the detailed description

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.

Conditions: Treatment Resistant Depression, Major Depressive Disorder, Treatment-Refractory Depression, Late Life Depression, Geriatric Depression
Being tested: Aripiprazole Augmentation, Bupropion Augmentation, Switch to bupropion, Lithium Augmentation, Switch to nortriptyline
Keywords: Comparative Effectiveness Research, Pragmatic Clinical Trials, Patient-Centered Outcomes Research
Medical subject headings: Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aripiprazole AugmentationDrug
Also called Abilify
Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
Bupropion AugmentationDrug
Also called Wellbutrin
Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
Switch to bupropionDrug
Also called Wellbutrin
Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
Lithium AugmentationDrug
Also called Lithium carbonate, Eskalith
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Switch to nortriptylineDrug
Also called Pamelor,
Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml

Study groups in NCT02960763
Study group	Role	What they receive
Aripiprazole Augmentation	Experimental	Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects. Receives: Drug: Aripiprazole Augmentation
Bupropion Augmentation	Experimental	Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects. Receives: Drug: Bupropion Augmentation
Switch to Bupropion	Experimental	Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects. Receives: Drug: Switch to bupropion
Lithium Augmentation	Experimental	Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L. Receives: Drug: Lithium Augmentation
Switch to Nortriptyline	Experimental	Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml. Receives: Drug: Switch to nortriptyline

What is being measured

The primary outcome is the main question the study is designed to answer.

Psychological Well-Being
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).
Measured: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Number of Participants With Remission From Depression
Remission defined as Montgomery Asberg Depression Rating Scale score ≤10. Scale ranges from 0-60 with higher scores indicating higher depressive symptoms.
Measured: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Serious Adverse Events
Life threatening illness, hospitalization, or need of medical care.
Measured: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 20171 Sep 2021

First posted10 Nov 2016 (estimated)
Study start24 Feb 2017
Primary completion28 Sep 2020
Study completion1 Sep 2021

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 Treatment Resistant DepressionStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 742 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02960763
Sponsor's protocol ID: 201609085
Other IDs: TRD-1511-33321
Acronym: OPTIMUM
Status last verified: Sep 2024
First submitted: 28 Oct 2016
Last updated: 3 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available through a Washington University in St. Louis (WUSTL) secure repository and registered at clinicaltrials.gov.

Publications

Oughli HA, Ainsworth NJ, Butters MA, Brown PJ, Gebara MA, Gettinger TR, Karp JF, Lavretsky H, Lenard E, Miller JP, Mulsant BH, Nicol GE, Reynolds CF 3rd, Yingling M, Lenze EJ; OPTIMUM Research Group. Cognitive changes in older adults receiving pharmacotherapy for treatment-resistant depression: a secondary analysis of the OPTIMUM randomised controlled trial. Lancet Healthy Longev. 2025 Oct;6(10):100767. doi: 10.1016/j.lanhl.2025.100767. Epub 2025 Nov 11.
PubMed 41237789
Srifuengfung M, Lenze EJ, Roose SP, Brown PJ, Lavretsky H, Karp JF, Reynolds CF 3rd, Yingling M, Sa-Nguanpanich N, Mulsant BH. Alcohol and substance use in older adults with treatment-resistant depression. Int J Geriatr Psychiatry. 2024 Jun;39(6):e6105. doi: 10.1002/gps.6105.
PubMed 38822571
Lenze EJ, Mulsant BH, Roose SP, Lavretsky H, Reynolds CF 3rd, Blumberger DM, Brown PJ, Cristancho P, Flint AJ, Gebara MA, Gettinger TR, Lenard E, Miller JP, Nicol GE, Oughli HA, Pham VT, Rollman BL, Yang L, Karp JF. Antidepressant Augmentation versus Switch in Treatment-Resistant Geriatric Depression. N Engl J Med. 2023 Mar 23;388(12):1067-1079. doi: 10.1056/NEJMoa2204462. Epub 2023 Mar 3.
PubMed 36867173

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression

All Treatment Resistant Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
ClinicalTrials.gov ID: NCT02960763
Acronym / sponsor ID: OPTIMUM / 201609085
Conditions: Treatment Resistant Depression, Major Depressive Disorder, Treatment-Refractory Depression, Late Life Depression, Geriatric Depression
Keywords: Comparative Effectiveness Research, Pragmatic Clinical Trials, Patient-Centered Outcomes Research
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 742 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute, National Institute of Mental Health (NIMH)
Study start: 24 Feb 2017 (actual)
Primary completion: 28 Sep 2020 (actual)
Study completion: 1 Sep 2021 (actual)
First posted: 10 Nov 2016 (estimated)
Results: Posted 24 May 2022

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

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Aripiprazole Augmentation	Experimental	Drug: Aripiprazole AugmentationAugment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Bupropion Augmentation	Experimental	Drug: Bupropion AugmentationAugment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Switch to Bupropion	Experimental	Drug: Switch to bupropionTaper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Lithium Augmentation	Experimental	Drug: Lithium AugmentationAugment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
Switch to Nortriptyline	Experimental	Drug: Switch to nortriptylineTaper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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 10 or higher

Key exclusion criteria (8 listed)

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.

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
Aripiprazole AugmentationAlso: AbilifyAugment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.	Drug	Aripiprazole Augmentation
Bupropion AugmentationAlso: WellbutrinAugment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.	Drug	Bupropion Augmentation
Switch to bupropionAlso: WellbutrinTaper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.	Drug	Switch to Bupropion
Lithium AugmentationAlso: Lithium carbonate, EskalithAugment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.	Drug	Lithium Augmentation
Switch to nortriptylineAlso: Pamelor,Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml	Drug	Switch to Nortriptyline

Primary outcome

Psychological Well-Being
Time frame: 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).
Number of Participants With Remission From Depression
Time frame: 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.
Serious Adverse Events
Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks
Life threatening illness, hospitalization, or need of medical care.

Results and safety

Results posted to the registry on 24 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole Augmentation	211	192
Bupropion Augmentation	206	188
Switch to Bupropion	202	174
Lithium Augmentation	0	0
Switch to Nortriptyline	0	0

Primary outcome: Psychological Well-Being

Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks. Mean (95% Confidence Interval). Unit: t-score

Measure	Aripiprazole Augmentation n = 211	Bupropion Augmentation n = 206	Switch to Bupropion n = 202	Lithium Augmentation n = 127	Switch to Nortriptyline n = 121
baseline	34.7 (33.8 to 35.6)	35.0 (34.1 to 36.0)	34.8 (33.8 to 35.7)	33.1 (31.9 to 34.4)	34.2 (32.9 to 35.4)
10 weeks	38.8 (37.9 to 39.8)	38.7 (37.8 to 39.7)	36.1 (35.1 to 37.2)	35.7 (34.4 to 37.1)	35.6 (34.3 to 37.0)

Aripiprazole Augmentation vs Bupropion Augmentation vs Switch to Bupropion: p = 0.010, ANOVA
Aripiprazole Augmentation vs Switch to Bupropion: p = 0.004, ANOVA
Bupropion Augmentation vs Switch to Bupropion: p = 0.017, ANOVA

Primary outcome: Number of Participants With Remission From Depression

Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks. Count of participants. Unit: Participants

Measure	Aripiprazole Augmentation n = 211	Bupropion Augmentation n = 206	Switch to Bupropion n = 202	Lithium Augmentation n = 127	Switch to Nortriptyline n = 121
Value	61	58	39	24	26

Aripiprazole Augmentation vs Bupropion Augmentation vs Switch to Bupropion: p = 0.038, generalized linear model with logistic l
Aripiprazole Augmentation vs Switch to Bupropion: p = 0.021, generalized linear model with logistic l
Bupropion Augmentation vs Switch to Bupropion: p = 0.027, generalized linear model with logistic l

Primary outcome: Serious Adverse Events

Time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks. Count of participants. Unit: Participants

Measure	Aripiprazole Augmentation n = 211	Bupropion Augmentation n = 206	Switch to Bupropion n = 202	Lithium Augmentation n = 127	Switch to Nortriptyline n = 121
Value	15	15	19	12	11

Aripiprazole Augmentation vs Bupropion Augmentation vs Switch to Bupropion: p = 0.164, Regression, Cox
Aripiprazole Augmentation vs Switch to Bupropion: p = 0.103, Regression, Cox
Bupropion Augmentation vs Switch to Bupropion: p = 0.127, Regression, Cox

Adverse events

Time frame: Adverse event data were collected during phone assessments every other week during Step 1 and Step 2 (approximately 10 weeks each) for approximately 20 weeks of event data.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole Augmentation	15 of 211 (7.1%)	148 of 211 (70.1%)	1 of 211
Bupropion Augmentation	15 of 206 (7.3%)	120 of 206 (58.3%)	1 of 206
Switch to Bupropion	19 of 202 (9.4%)	136 of 202 (67.3%)	1 of 202
Lithium Augmentation	12 of 127 (9.4%)	93 of 127 (73.2%)	0 of 127
Switch to Nortriptyline	11 of 121 (9.1%)	93 of 121 (76.9%)	0 of 121

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41237789Oughli HA, Ainsworth NJ, Butters MA, Brown PJ, Gebara MA, Gettinger TR, Karp JF, Lavretsky H, Lenard E, Miller JP, Mulsant BH, Nicol GE, Reynolds CF 3rd, Yingling M, Lenze EJ; OPTIMUM Research Group. Cognitive changes in older adults receiving pharmacotherapy for treatment-resistant depression: a secondary analysis of the OPTIMUM randomised controlled trial. Lancet Healthy Longev. 2025 Oct;6(10):100767. doi: 10.1016/j.lanhl.2025.100767. Epub 2025 Nov 11.
Derived from this study: PubMed 38822571Srifuengfung M, Lenze EJ, Roose SP, Brown PJ, Lavretsky H, Karp JF, Reynolds CF 3rd, Yingling M, Sa-Nguanpanich N, Mulsant BH. Alcohol and substance use in older adults with treatment-resistant depression. Int J Geriatr Psychiatry. 2024 Jun;39(6):e6105. doi: 10.1002/gps.6105.
Derived from this study: PubMed 36867173Lenze EJ, Mulsant BH, Roose SP, Lavretsky H, Reynolds CF 3rd, Blumberger DM, Brown PJ, Cristancho P, Flint AJ, Gebara MA, Gettinger TR, Lenard E, Miller JP, Nicol GE, Oughli HA, Pham VT, Rollman BL, Yang L, Karp JF. Antidepressant Augmentation versus Switch in Treatment-Resistant Geriatric Depression. N Engl J Med. 2023 Mar 23;388(12):1067-1079. doi: 10.1056/NEJMoa2204462. Epub 2023 Mar 3.
Individual participant dataSharing planned: Yes. A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available through a Washington University in St. Louis (WUSTL) secure repository and registered at clinicaltrials.gov.

Related trials for Treatment Resistant Depression

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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.

Eric Lenze, MD principal investigator

Washington University School of Medicine

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 3 Oct 2024. 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, Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 24 May 2022). 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?

Psychological Well-Being (time frame: Step 1 (10 weeks), Step 2 (10 weeks), a period of up to 20 weeks). The study lists 3 primary outcomes in all. 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 NCT02960763, 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 3 Oct 2024.