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Vortioxetine Fails to Outperform Placebo in Phase 2 Trial of Adults With ADHD

The antidepressant Trintellix (vortioxetine, marketed as Brintellix outside United States) may be no more effective than placebo at reducing symptoms of attention-deficit/hyperactivity disorder (ADHD) in adults, according to third quarter results released this week by H. Lundbeck A/S.
For the phase 2 trial, 227 adults with ADHD aged 18 to 55 were randomly assigned to placebo or vortioxetine for 12 weeks. “[V]ortioxetine failed to achieve significance in separating from placebo,” the company wrote.
In April, the Food and Drug Administration declined Lundbeck’s request to expand the antidepressant’s approval to treat cognitive dysfunction in adults with major depressive disorder. ■

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Published online: 4 November 2016
Published in print: November 4, 2016

Keywords

  1. ADHD
  2. Trintellix
  3. Brintellix
  4. Lundbeck
  5. FDA
  6. antidepressant
  7. vortioxetine

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