OPTIMUM is a research
study designed to test which medications work best and are safest for adults age sixty and older with difficult-to-treat depression.

Who is eligible
for OPTIMUM?

You may be eligible if you...
  • Age 60 years old or older.
  • Have depression despite having tried two or more antidepressants in the past.
Patients may be excluded if they...
  • Have severe memory impairment or another medical illness that is not currently controlled.

Ask your doctor about
the OPTIMUM study
  • Eligible Participants are randomized to one of three medication strategies.
  • The study team will assess your side effects and mood by phone every other week.
  • Study geriatric psychiatrists provide medication recommendations to your primary care physician.

You Talked, We Listened

We spoke to older adults living with depression to find out what is important in a research study. Here’s what we learned is important:
 
  •  Psychological well-being is the most important outcome.
 
  • That risks of treatments, as well as benefits, should be measured – including falls and side effects of medication.

  • The research team will support your doctor in managing your depression treatment by checking in with you by phone.

OPTIMIZE your treatment

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THE STUDY
OPTIMUM is a research study designed to test which medications work best and are safest for older adults with difficult to treat depression.
 
MEDICATIONS
In the first stage participants will be randomized to receive aripiprazole or bupropion. If these medications are not effective participants will be randomized to receive lithium or notriptyline in the second stage.
 
DECISION SUPPORT
Research staff will call patients every two weeks to check in about any continued symptoms, side effects, and medical compliance. Research staff will also stay in touch with your doctor to ensure the safe and effective use of antidepressants in this elderly population.

RESEARCH ASSESSMENTS
You will be asked to complete up to 6 research assessment visits while you are in the study. These approximately hour-long visits will include measurements of your symptoms of depression, side effects, physical function, mood, and emotions. After each visit another staff will conduct phone assessment with you lasting about 20 to 30 minutes.

Participants will be reimbursed for their time.                                

OPTIMUM medication information

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.
OPTIMUM is a multi-site research study. © Copyright 2017 All rights reserved.