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

NCT01944969 | Terminated Phase 3 Results

• 2 other identifiers: 14767B2012-004169-42
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Emergent Adverse Events

  Number of participants with Treatment-Emergent Adverse Events

  From baseline to Week 52

• Number of Withdrawals

  Number of withdrawals

  From baseline to Week 52

Secondary Outcomes (6)

• Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)

  From baseline to Week 52

• Change in Depressive Symptoms

  From baseline to Week 52

• Proportion of Patients in Remission

  From baseline to Week 52

• Change in Clinical Global Impression

  From baseline to Week 52

• Change in Health-related Quality of Life

  From baseline to Week 52

Study Arms (1)

Brexpiprazole

EXPERIMENTAL

Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)

Brexpiprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

US008

Orlando, Florida, 32806, United States

Location

Related Links

• EudraCT (EMA) Result Posting

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

Because the study was terminated, few efficacy data were collected. These data have not been reported in accordance with the ICH E3 regarding abbreviated clinical study reports. Furthermore, no firm conclusions can be drawn regarding safety.

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+45 36301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 17, 2018
• Results First Posted: March 3, 2016

Record last verified: 2018-09

Locations

US (1)