Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder

Stopped early · Phase 3

Conditions studied: Major Depressive Disorder

In brief

To evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with Major Depressive Disorder (MDD)

Key facts

Study ID

NCT01944969

Run by

H. Lundbeck A/S

People needed

26

Starts

2013-10-01

Expected to finish

2014-05-01

Last updated by the study team

2018-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
• The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A or NCT01837797 / 14571A, diagnosed according to DSM-IV-TR™.
• The patient agrees to protocol-defined use of effective contraception.

You may not qualify if…

• The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
• The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies NCT01838681 / 14570A or NCT01837797 / 14571A.
• The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide.
• The patient has any relevant medical history or current presence of systemic disease.
• The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
• The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator.
• The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
• Other inclusion and exclusion criteria may apply.

Where it is running

• US008 — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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