Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

• Drug: desvenlafaxine succinate sustained-release 50 mg/day
  50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper
  Other Name: Pristiq
• Drug: desvenlafaxine succinate sustained-release 100 mg/day
  100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day
• Drug: placebo
  50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper

• Experimental: desvenlafaxine succinate sustained-release 50 mg/day
  Intervention: Drug: desvenlafaxine succinate sustained-release 50 mg/day
• Experimental: desvenlafaxine succinate sustained-release 100 mg/day
  Intervention: Drug: desvenlafaxine succinate sustained-release 100 mg/day
• Placebo Comparator: Placebo
  Intervention: Drug: placebo

• McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.
• Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
• Clayton AH, Tourian KA, Focht K, Hwang E, Cheng RF, Thase ME. Desvenlafaxine 50 and 100 mg/d versus placebo for the treatment of major depressive disorder: a phase 4, randomized controlled trial. J Clin Psychiatry. 2015 May;76(5):562-9. doi: 10.4088/JCP.13m08978.

Inclusion Criteria:

• Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
• A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
• A HAM-D17 total score ?20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Exclusion Criteria:

• Significant risk of suicide based on clinical judgment.
• Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
• Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
• History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
• Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.