NCT01360866 — drugset

Summary

To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)

Timeline

Start: 2011-10
Primary completion: 2017-04-18
Completion: 2017-05-18

Publications

Newcomer JW, Meehan SR, Chen D, Brubaker M, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies. J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786.
Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexpiprazole	Small molecule	0.5 mg	Oral
Subject	Brexpiprazole	Small molecule	3 mg	Oral
Background	Duloxetine	Small molecule	40 mg	Oral
Background	Duloxetine	Small molecule	60 mg	Oral
Background	Escitalopram	Small molecule	10 mg	Oral
Background	Escitalopram	Small molecule	20 mg	Oral
Background	Fluoxetine	Small molecule	20 mg	Oral
Background	Fluoxetine	Small molecule	40 mg	Oral
Background	Paroxetine	Small molecule	37.5 mg	Oral
Background	Paroxetine	Small molecule	50 mg	Oral
Background	Sertraline	Small molecule	100 mg	Oral
Background	Sertraline	Small molecule	150 mg	Oral
Background	Sertraline	Small molecule	200 mg	Oral
Background	Venlafaxine	Small molecule	75 mg	Oral
Background	Venlafaxine	Small molecule	150 mg	Oral
Background	Venlafaxine	Small molecule	225 mg	Oral

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

Summary

Timeline

Publications

Drugs

Indications