DRUG FACTS ABILIFY (aripiprazole) for adults with major depression that persists on antidepressants What is this drug for?
To reduce symptoms of major depression– nearly everyday feelings of
Who might consider taking it?
Adults with major depression that persists after one or more 8-week courses
How long has the drug been used? First approved in 2002 for schizophrenia; in 2007 for persistent depression
(based on studies of about 1,000 people). As with all drugs, rare but serious side effects may emerge when more people use it for a new purpose.
What precautions should I take?
Use caution driving or operating machinery because ABILIFY may impair
judgment, thinking or motor skills. Do not drink alcohol or breastfeed. Check blood tests if youʼve' had low white blood cell count or high sugar levels.
What other choices are there?
Cognitive behavioral psychotherapy, exercise, switch to a different anti-
depressant, add another anti-depressant, or electroconvulsive therapy.
STUDY FINDINGS
381 people (19-67 years old) with major depression that that persisted after 8 weeks of anti-depressant had either ABILIFY or PLACEBO added for 6 weeks. Here's what happened: What difference did ABILIFY make? How did ABILIFY help?
People had lower depression scores - their score improved by
3 points more than placebo (on a scale from 0 to 60).
More people were "no longer depressed" based on score
(10% "no longer depressed" due to drug)
What were ABILIFY'S side effects? WARNING ABOUT UNCOMMON SERIOUS OR LIFE-THREATING SIDE EFFECTS
Young adults using anti-depressants for major depression have a higher risk of suicidal thinking and behavior. Elderly patients with dementia-related psychosis should not use antipsychotic drugs because of increased death. Atypical antipsychotic drugs– like ABILIFY- cause: Neuroleptic Malignant Syndrome (very high fever and blood pressure, delirium), Tardive Dyskinesia (uncontrollable facial / body movements), Dangerous Heart Rhythms, Seizures, Low White Blood Cell Counts, Trouble Swallowing, Aspiration Pneumonia, Diabetes, Low Blood Pressure, Trouble Regulating Body Temperature Serious side effects (serious and symptom side effects based on 737 people studied for 6 weeks)
More people developed akathisia - severe restlessness that
makes it hard to keep still (21% had akathisia due to drug)
More people developed movement disorders –such as
Parkinson's-like rigidity, tics (3% had movement disorders due to drug)
Symptom side effects
More had insomnia (6% had insomnia due to drug)
More had blurred vision (5% had insomnia due to drug)
More had substantial weight gain (4% had weight gain due to drug)
More had fatigue (4% had fatigue due to drug)
More had constipation (3% had constipation due to drug)
Uncertainties
The 2 trials done for approval (this and an identical one with 362 people) cannot establish if ABILIFY is effective or safe beyond 6 weeks – or better than the alternatives. It is uncertain if the drug helps people function better– one trial showed it did, the other didn't.
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