NCT01987960

Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Study of Brexpiprazole as Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 417 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine (PAR) or sertraline (SER) on PTSD symptoms.

Conditions

• Post-traumatic Stress Disorder
• PTSD

Interventions

Type	Name	Description
DRUG	Placebo	Once daily, tablets, orally
DRUG	Brexpiprazole	1 to 3 mg/day, once daily dose, tablets, orally

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-11-20
• Last updated: 2017-03-13
• Results posted: 2017-03-13

Locations

59 sites across 9 countries: United States, Estonia, Finland, France, Italy, Poland, Serbia, South Africa, Sweden