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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

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing different medication strategies to help older adults whose depression hasn't improved with standard treatments. Participants will try new combinations or replacements of their current antidepressants. The goal is to find more effective treatments and understand how these changes affect memory and brain 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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-months, 24-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Other study objectives

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 • NCT02960763

20%

Dizziness

17%

Irritability or Emotional Lability

15%

Nausea/Vomiting

14%

Tension/Inner Unrest

11%

Cold/Flu Symptoms

11%

Reduced Salivation

Constipation

Non-psychiatric Hospitalization

Headache

Fall

Tremor

Concenctration Difficulties

Diarrhea

Increased Appetite Without Weight Gain

Polyuria/Polydipsia

Increased Tendency to Sweating

Akathisia

Sleepiness/Sedation

Asthenia/Lassitude/Increased Fatiguability

100%

80%

60%

40%

20%

Study treatment Arm

Switch to Bupropion

Bupropion Augmentation

Aripiprazole Augmentation

Lithium Augmentation

Switch to Nortriptyline

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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