Optimum

Improving treatment for adults 60+ who are currently depressed and taking antidepressant medication

What is the purpose of the study?

The Optimum research study aims to find the safest approach to treating depression in older adults with treatment-resistant depression.

Depression may be considered treatment-resistant if you have tried antidepressant medications, but not found relief from your symptoms. Many of our Optimum participants have struggled to find effective treatment for many years.

Symptoms of depression may include: 

  • Feeling sad, down or blue
  • Loss of interest or pleasure in activities you used to enjoy
  • Feeling guilty or worthless
  • Fatigue or lack of energy
  • Difficulty concentrating or making decisions
  • Sleeping too much or too little
  • Loss of appetite or overeating
  • Feeling slowed down or feeling restless
  • Thoughts of death or that life is not worth living

If you are taking an antidepressant and you still have some of these symptoms, you may be eligible for Optimum.

To find out more about the study, and see if you are eligible, click “Register now” below.

Eligibility

You may be eligible if you are…

  • Age 60+
  • Currently depressed
  • Currently taking an antidepressant medication

What is involved in the study?

The treatment groups

In the first stage of the study, you will be randomized to either add aripiprazole or bupropion to your current treatment or you will switch to taking only bupropion. Many participants ask what it means to be randomized and may assume that some groups receive a control, or placebo. In the Optimum study, there is no control or placebo group. If you participate, you will receive treatment. Being randomized to one of the three treatments simply means you do not choose which treatment you will receive. Researchers place you in a treatment group randomly, like flipping a coin.

If the treatment is not effective, you will move to the second stage of the study. In the second stage of the study, you will be randomized to receive lithium or notriptyline.

More information about the study medications can be found below.

Additional support

Research staff will call every two weeks to check in about your response to treatment, any continued symptoms, side effects, and medical compliance. Research staff will also stay in touch with your doctor to  ensure you receive coordinated care.

Study visits

You will be asked to complete 3-4 visits while you are in the study. The first visit is the baseline visit where we will learn more about you, your depression symptoms, your treatment history, as well as current physical function. The baseline visit takes around 4 hours to complete, but can be broken into two, 2-hour visits. The 10-week and 1-year visits take about 2 hours. After each visit another staff will conduct phone assessment with you lasting about 20 to 30 minutes.
 

What medications are involved in the study?

Aripiprazole

Aripiprazole is a medication that is added to an antidepressant to augment (boost) its effect, helping patients get better from depression. It is generally safe, well-tolerated, and effective for older adults.

  • Take this medication as prescribed. Typically it is taken once daily, in the morning, but if you feel sedation from it, you can move it to night-time.
  • You may take aripiprazole with or without food.
    If you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
  • An electrocardiogram (ECG) is a test that records the heart’s rhythm and activity. This test will be obtained within 12 months prior to initiating aripiprazole.
    If aripiprazole helps your depression, it is likely to continue to help if you remain on this medication long term. If so, we will recommend that your doctor routinely monitor your blood sugar and lipids.
  • Talk with your doctor or OPTIMUM study staff before starting any new drug, including prescription or Over-The-Counter drugs, natural products, or vitamins.
  • This medication is covered by insurance, Medicare part D and by your state’s Medicaid. This medication is available as a generic. The generic works just as well as the more expensive brand-name. Any denials from your insurance company should be appealed and we will assist you with this process.

Side Effects of ARIPIPRAZOLE:
Likely / Common (one in four may experience these side effects and are usually mild/temporary).

  • Feeling shaky or restless
  • Increased appetite

Less Likely / Less Common

  • Insomnia, fatigue, blurred vision, somnolence, tremor, constipation, sedation, dizziness
  • Notify your doctor or OPTIMUM study staff for concerns related to any side effects.

However, if you experience any of the following rare side effects — High fevers, muscle rigidity, confusion, large increase or drop in blood pressure or very rapid heartbeat — contact your doctor or OPTIMUM study staff immediately.

Bupropion

Bupropion is antidepressant medication used to treat major depressive disorder.

  • Take this medication once daily every morning (or as prescribed by your doctor).
  • You may take bupropion with or without food. Take it with food if causes an upset stomach.
  • Swallow bupropion whole. Do not break or crush.
  • If you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
  • Talk with your doctor or OPTIMUM study staff before starting any new drug, including prescription or Over-The-Counter drugs, natural products, or vitamins.
  • This medication is covered by insurance, Medicare part D and by your state’s Medicaid. This medication is available as a generic. The generic works just as well as the more expensive brand-name. Any denials from your insurance company should be appealed and we will assist you with this process.

Side Effects of BUPROPION — These side effects are usually mild/temporary. Notify your doctor or OPTIMUM study staff for concerns related to any of these:

Common

  • Agitation, dry mouth, headache, decreased appetite

Less Common

  • Nausea, constipation
  • High blood pressure (note: if you already have high blood pressure, this does not mean that bupropion will worsen it).
  • Heart pounding
  • Excessive sweating, increased urination
  • Dizziness, tremor, imbalance
  • Anxiety, confusion, difficulty sleeping
  • Rash

Seizure is a very rare side effect (less than 1 in 500 persons); if you think you have had a seizure, contact your doctor or OPTIMUM study staff immediately.

Lithium

Lithium is a naturally occurring salt. It is well-known for treating bipolar disorder (“manic depression”) but it is also used at a lower dose, as an add-on treatment for depression. Added to your current antidepressant, it can be effective for improving depression.

Lithium is typically taken once daily at bedtime (or as prescribed by your doctor).

  • You may take lithium with or without food. Take it with food if causes an upset stomach.
  • If you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
  • Keep well-hydrated, especially in the summer. Dehydration can cause the lithium level to increase in your system.
  • If you respond to lithium and remain on this medication, we will recommend that your doctor routinely monitor your electrolytes (e.g., potassium and sodium levels in the body), thyroid and kidney function.
  • Lithium is most effective, and well-tolerated, when it is at a certain blood level range. Therefore, after you start taking lithium we will recommend checking lithium level in your blood to make sure you are taking the right amount for you.
  • Certain drugs can affect lithium levels. Discuss with your doctor or OPTIMUM study staff if you are taking now or plan to begin taking:
    • Non-Steroidal Anti-inflammatory Drugs (NSAID’s) such as ibuprofen/Motrin, naproxen/Aleve
    • These blood pressure/heart medicines: losartan (Cozaar), valsartan (Diovan) enalapril (Vasotec), ramipril (Altace), lisinopril (Lopril), perindopril (Coversyl), hydrochlorothiazide (HCTZ) and furosemide (Lasix).
  • If you need pain medication on occasion, take acetaminophen (Tylenol) which does not affect lithium.
  • Talk with your doctor or OPTIMUM study staff before starting any new drug, including prescription or Over-The-Counter drugs, natural products, or vitamins.
  • This medication is covered by insurance, Medicare part D and by your state’s Medicaid. This medication is available as a generic. The generic works just as well as the more expensive brand-name. Any denials from your insurance company should be appealed and we will assist you with this process.

Side Effects of LITHIUM:


Likely / Common (about one in five may experience these side effects and are usually mild/temporary)

  • Shakiness of the hands
  • Upset stomach
  • Drowsiness, headache
  • Dry mouth, increased urination, increased thirst

Notify your doctor or OPTIMUM study staff for concerns related to any of the side effects listed above. Most side effects should resolve after the body adjusts over 1-2 weeks.

However, if you experience any of these rare side effects, contact your doctor or OPTIMUM study staff immediately: Muscular weakness and lack of coordination/balance, altered consciousness, blurred vision, convulsions (seizures), slurred speech, fainting, marked shakiness, vomiting, diarrhea. These may be signs of a too-high lithium level.

Nortriptyline

Nortriptyline is an antidepressant that has been shown to be effective in older adults.

Take this medication once daily at bedtime (or as prescribed by your doctor).

  • You may take nortriptyline with or without food. Take it with food if it causes an upset stomach.
  • If you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
  • An electrocardiogram (ECG) is a test that records the heart’s rhythm and activity. The test will be obtained while taking nortriptyline once a therapeutic blood level has been achieved.
  • Nortriptyline is most effective when a patient achieves a certain level of it in their blood. Therefore, nortriptyline blood tests will be recommended to confirm that you have achieved this optimal level.
  • Talk with your doctor or OPTIMUM study staff before starting any new drug, including prescription or Over-The-Counter drugs, natural products, or vitamins.
  • This medication is covered by insurance, Medicare part D and by your state’s Medicaid. This medication is available as a generic. The generic works just as well as the more expensive brand-name. Any denials from your insurance company should be appealed and we will assist you with this process.

Side Effects of NORTRIPTYLINE — Notify your doctor or OPTIMUM study staff for concerns related to any of these:

Common

  • Dry mouth (50% of patients; if bothersome, can be treated)
  • Constipation (one in five patients; typically mild and temporary, if not can be easily treated)
  • Sweating (less than one in five patients; usually mild, temporary)

Less common

  • Hypotension (low blood pressure), rapid pulse
  • Blurred vision, dizziness, headache
  • Difficulty urinating

If you experience side effects such as low blood pressure, lightheadedness, rapid heart rate, we may recommend your doctor monitor blood pressure and pulse as needed.

Frequently Asked Questions

Are the study medications covered by insurance?

All study medications are covered by private insurance, Medicare part D and by your state’s Medicaid. The medications are also available as generics. The generics work just as well as the brand-name. Any denials from your insurance company should be appealed and we will assist you with this process.

Will I be compensated?

Over the course of the study, if you are eligible and participate, you may be compensated up to $240.

What is the time commitment for this study?

The study lasts up to 18 months. The study involves 3-4 in-person visits at the Healthy Mind Lab located at 600 S. Taylor Avenue, St. Louis, MO 63108. The study also involves phone calls every 2 weeks for the first 10 weeks of the study where our team will check on your depression symptoms and medication side effects. 

In the study, will I change my medication?

You will be asked to add on an additional medication or switch to a different medication. A Washington University physician will work with you to determine the best dosage. 

Will Optimum be in touch with my physician during the study?

The Optimum team and study physicians will stay in touch with your current provider throughout the study.

Is the Optimum study being conducted at other institutions other than Washington University in St. Louis School of Medicine?

The Optimum study is being conducted at 5 sites across North America: St. Louis, New York City, Pittsburgh, Los Angeles and Toronto. You can learn more about the study and the other sites involved at optimumstudy.org

How do I get to The Healthy Mind Lab?

The Healthy Mind Lab is located in the Institute for Public Health Building which is also known as the Taylor Avenue Building.

Address
600 S. Taylor Ave., Suite 121, St. Louis, MO 63110

Parking

  • Free parking for study participants is available in the lot behind the building.
  • Free visitor parking is available in two-hour increments in the lot in front of the building along Taylor Avenue.
  • Hourly parking is available in the Clayton Avenue garage just south of our location at the corner of Clayton and Taylor Avenues. Parking meters are available along Scott Avenue.


Public Transit

  • The Central West End MetroLink station and the Central West End Transit Center bus stop is located one block west of our location.

Please let us know if you have circumstances that make traveling to our campus difficult for you and we will do our best to accommodate.

Click “Register now” to find out if you might be eligible for the study or call 314-273-7034.

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