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Atypical Antipsychotic
Antidepressant Strategies for Late-Life Depression (ONR Trial)
Phase 4
Waitlist Available
Led By Aristotle Voineskos, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-months, 24-months
Awards & highlights
ONR Trial Summary
This trial is testing different antidepressants to see which work best for older adults with treatment-resistant depression, and whether this type of depression is linked to problems with memory, attention, and brain structure or function.
Who is the study for?
This trial is for adults aged 60 and older with treatment-resistant depression, meaning they haven't gotten better after trying at least two different antidepressants. They must have a diagnosis of Major Depressive Disorder and a certain level of depressive symptoms. People with bipolar disorder, schizophrenia, dementia, severe hearing loss, unstable illnesses like uncontrolled diabetes or high suicide risk cannot join.Check my eligibility
What is being tested?
The study tests whether adding Aripiprazole or Lithium to current treatment helps more than switching to Bupropion or Nortriptyline in older adults with resistant depression. It also looks at how these treatments affect memory, attention and brain structure/function over time.See study design
What are the potential side effects?
Possible side effects include weight gain, sleepiness or insomnia, headaches, dry mouth from Aripiprazole; seizures from Bupropion; thirstiness, tremors from Lithium; and constipation or blurred vision from Nortriptyline.
ONR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6-months, 24-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-months, 24-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessing the change in the Number of Participants With Remission From Depression
Change in Psychological Well-Being
Safety Outcomes Assessment for Serious Adverse Events
+1 moreOther outcome measures
Plasma biomarkers will be analyzed using a customized multiplex protein array platform for the Senescence-Associated Secretory Phenotype (SASP).
Side effects data
From 2021 Phase 4 trial • 742 Patients • NCT0296076317%
Dizziness
15%
Weight gain
14%
Tension/Inner Unrest
14%
Cold/Flu Symptoms
11%
Increased Appetite Without Weight Gain
11%
Akathisia
9%
Asthenia/Lassitude/Increased Fatiguability
9%
Sleepiness/Sedation
8%
Headache
7%
Reduced Salivation
7%
Constipation
7%
Tremor
7%
Nausea/Vomiting
7%
Diarrhea
7%
Non-psychiatric Hospitalization
5%
Irritability or Emotional Lability
5%
Fall
5%
Concenctration Difficulties
2%
Polyuria/Polydipsia
2%
Increased Tendency to Sweating
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aripiprazole Augmentation
Switch to Bupropion
Lithium Augmentation
Bupropion Augmentation
Switch to Nortriptyline
ONR Trial Design
5Treatment groups
Experimental Treatment
Group I: Switch to NortriptylineExperimental Treatment1 Intervention
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.
Group II: Switch to BupropionExperimental Treatment1 Intervention
Taper from current antidepressant therapy. Start bupropion once-daily extended, titrated from 150-300 mg daily based on symptom severity and side effects.
Group III: Lithium AugmentationExperimental Treatment1 Intervention
Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 mEq/L (milliequivalents/liter).
Group IV: Bupropion AugmentationExperimental Treatment1 Intervention
Augment current antidepressant treatment with bupropion once-daily extended release, titrated from 150-300 mg daily based on symptom severity and side effects.
Group V: Aripiprazole AugmentationExperimental Treatment1 Intervention
Augment current antidepressant treatment with aripiprazole (tablets), titrated from 2-15 mg daily based on symptom severity and side effects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aripiprazole Augmentation
2017
Completed Phase 4
~750
Bupropion Augmentation
2017
Completed Phase 4
~750
Switch to bupropion
2017
Completed Phase 4
~750
Lithium Augmentation
2017
Completed Phase 4
~750
Switch to nortriptyline
2017
Completed Phase 4
~750
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
354 Previous Clinical Trials
80,520 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,688,507 Total Patients Enrolled
Aristotle Voineskos, MDPrincipal InvestigatorCentre for Addiction and Mental Health
2 Previous Clinical Trials
820 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your PHQ-9 score is 10 or higher.I have a seizure disorder.My health conditions like diabetes or high blood pressure are not well-controlled.I have tried at least two antidepressants for 12 weeks each without improvement.I have Parkinson's Disease.I have been diagnosed with Major Depressive Disorder.I have tried at least two antidepressants for 12 weeks each without improvement.I have been diagnosed with Major Depressive Disorder.I have been diagnosed with a serious mental health condition like bipolar disorder or schizophrenia.I am 60 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Aripiprazole Augmentation
- Group 2: Bupropion Augmentation
- Group 3: Switch to Bupropion
- Group 4: Lithium Augmentation
- Group 5: Switch to Nortriptyline
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Late-Life Depression Patient Testimony for trial: Trial Name: NCT05531591 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent could Aripiprazole Augmentation be detrimental to patients?
"The safety of Aripiprazole Augmentation is rated a 3 based on the Phase 4 trial data, which has shown this treatment to be approved."
Answered by AI
To what extent is this trial being implemented in medical facilities?
"This clinical trial is recruiting participants from a variety of medical centres, including the Washington University School of Medicine Healthy Mind Lab in Saint Louis, Missouri; the Centre for Addiction and Mental health in Toronto, Ontario; Columbia University Adult and Late Life Depression Clinic in New york, New York; as well as four additional sites."
Answered by AI
Is this medical investigation currently enrolling participants?
"Unfortunately, based on what is posted to clinicaltrials.gov this study has concluded recruitment of volunteers and does not require any further participants at present. The trial was first launched in August 2019 and last updated in September 2022. Nonetheless, there are still 2149 other trials that have open enrollment currently available for those seeking an opportunity to participate in medical research."
Answered by AI
Who else is applying?
What state do they live in?
California
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
What site did they apply to?
Columbia University Adult and Late Life Depression Clinic
UCLA Late-Life Mood, Stress, and Wellness Research Program
Why did patients apply to this trial?
I have tried many times to overcome my depression and none has worked to date.
PatientReceived 1 prior treatment
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