Abilify

Aripiprazole

For Major Depression

Track record

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Long (approved in 2007)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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Major Depression

What is Major Depression?

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Being sad, blue, or unhappy at times is a normal part of life. But being seriously “down” or depressed for a prolonged period—more than two weeks or so—may not be normal and can usually be helped with appropriate treatment.

Other treatments for Major Depression

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

Bottom Line

Adding Abilify to an antidepressant for persistent depression is a tradeoff

Adding Abilify to an antidepressant for persistent depression is a tradeoff: some people’s depression will improve but more will experience a serious side effect – uncontrollable restlessness (akathisia). And some will gain a substantial amount of weight.

The FDA reviewer was concerned that side effects like weight gain, sedation and serious movement disorders may be worse or more common when Abilify is combined with antidepressants

The 2 FDA-approval studies combined below had nearly identical findings about how much the drug helped over 6 weeks. This makes the numbers in the table more believable. Benefits and side effects over a longer time are more uncertain.

May 2016 Update: FDA issued a warning that Abilify can cause rare but serious impulse-control problems

Pathological gambling, compulsive eating, compulsive shopping, and compulsive sexual behavior have been reported in people taking Abilify. These uncontrollable and excessive behaviors stopped when the dose was reduced or the drug was stopped. Talk to your doctor right away if you or a family member take Abilify and develop new or increased gambling urges, sexual urges, uncontrolled spending, binge eating, or other urges that seem out of the ordinary. Do not suddenly stop taking Abilify without first talking to your doctor.

FDA-approved use

To add-on to current antidepressant if major depression persists

Abilify is not approved as a first-choice drug - or to be used alone - for major depression. Abilify is NOT approved for treating the elderly with dementia.

Who might consider taking it?

Adults with major depression that persists on antidepressants

People with major depression that persists after trying other antidepressants. Major depression is when people have nearly everyday feeling of extreme sadness or hopelessness or thoughts of death and suicide that interfere with daily life. Other symptoms include loss of interest or pleasure in activities you used to enjoy, important change in weight or appetite, difficulty sleeping or oversleeping, energy loss, and feelings of worthlessness.

What is not known

Dementia-related psychosis

Abilify is not approved for the treatment of patients with dementia-related psychosis associated with Alzheimer's disease due to an increased risk of death. Benefits and harms of Abilify in the treatment of people with dementia-related psychosis have not been established.

Track record

LONG TRACK RECORD

Long track record means that new‚ unexpected side effects are unlikely. Abilify was first approved by FDA in 2002 for schizophrenia and approved for persistent depression in 2007. Since Abilify has now been used by large numbers of people over a longer time for persistent depression‚ the emergence of rare but serious side effects is less likely than with new drugs.

Open questions

NO ONGOING STUDIES

Do not take if you...

Allergic to Abilify (aripiprazole)

Safe if pregnant or breastfeeding?

Pregnant

Only take if potential benefits outweigh potential harm to baby (FDA Category C)

Breastfeeding

Do not breastfeed - Abilify gets into breast milk and can harm baby. Either stop breastfeeding or stop Lyrica.

NEXT: TRIALS

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