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Trial record 20 of 64 for:    brexpiprazole

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01944969
Recruitment Status : Terminated (The study was terminated because the lead-in study (14571A) in elderly was terminated; see Detailed Description.)
First Posted : September 18, 2013
Results First Posted : March 3, 2016
Last Update Posted : October 17, 2018
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Brexpiprazole Phase 3

Detailed Description:
This extension safety study was terminated early because one of the lead-in studies (14571A) in elderly was terminated and because the Sponsor considered that sufficient long-term safety data has already been collected in the development programme in the population aged 18-65 yrs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, Long-term Extension Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder
Study Start Date : October 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Brexpiprazole
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Drug: Brexpiprazole
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)

Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: From baseline to Week 52 ]
    Number of participants with Treatment-Emergent Adverse Events

  2. Number of Withdrawals [ Time Frame: From baseline to Week 52 ]
    Number of withdrawals

Secondary Outcome Measures :
  1. Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) [ Time Frame: From baseline to Week 52 ]
    The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.

  2. Change in Depressive Symptoms [ Time Frame: From baseline to Week 52 ]
    The Montgomery and Aasberg Depression Rating Scale (MADRS) total score

  3. Proportion of Patients in Remission [ Time Frame: From baseline to Week 52 ]
    Based on a pre-specified MADRS total score

  4. Change in Clinical Global Impression [ Time Frame: From baseline to Week 52 ]
    Clinical Global Impression - Severity of illness (CGI-S) score

  5. Change in Health-related Quality of Life [ Time Frame: From baseline to Week 52 ]
    Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score

  6. Change in Health-related Quality of Life [ Time Frame: Baseline and Week 52 ]
    The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient's wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01944969

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United States, Florida
Orlando, Florida, United States, 32806
Sponsors and Collaborators
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
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Study Director: Email contact via H. Lundbeck A/S

Additional Information:
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Responsible Party: H. Lundbeck A/S Identifier: NCT01944969     History of Changes
Other Study ID Numbers: 14767B
2012-004169-42 ( EudraCT Number )
First Posted: September 18, 2013    Key Record Dates
Results First Posted: March 3, 2016
Last Update Posted: October 17, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents