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Trial record 4 of 64 for:    brexpiprazole

A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03737474
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
This trial is a 52-week safety study to evaluate the safety of adjunctive Brexpiprazole in outpatients with major depressive disorder.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label Trial to Assess the Long-term Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexpiprazole
2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily
Drug: Brexpiprazole
2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily




Primary Outcome Measures :
  1. The frequency of Adverse Events [ Time Frame: From baseline to week 52 ]

    The incidence of the following events will be summarized:

    •Adverse events occurring after initiation of Interventional Medicinal Product administration



Secondary Outcome Measures :
  1. Mean changes from baseline in Montgomery Åsberg Depression Rating Scale(MADRS) at Week 52. [ Time Frame: Baseline and Week 52 ]
    The proportion of subjects who decrease MADRS total scores more than 50%. Reaction Rate and Remission Rate.The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.

  2. The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) scale at Week 52 [ Time Frame: Baseline and Week 52 ]
    The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.

  3. Mean changes from baseline in Clinical Global Impression-Severity of illness(CGI-S) at Week 52 [ Time Frame: Baseline and Week 52 ]
    The CGI-S Scale is a clinician-rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.

  4. Mean changes from baseline in Hamiliton Depression Rating Scale(HAM-D) item total scores at Week 52 [ Time Frame: Baseline and Week 52 ]
    The HAM-D is a clinician-rated scale which evaluates the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on. Each item is scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 53 , with higher score indicating worse condition.

  5. Mean changes from baseline in Sheehan Disability Scale (SDS) scores at Week 52 [ Time Frame: Baseline and Week 52 ]
    SDS Scale is a patient-rated scale which assesses the degree of impairment for each of 3 items ("work/school," "social life," and "family life/home responsibilities") on a 11-point scale ranging from 0 to 10 and the number of "days lost" and "days unproductive" caused by in the past week.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rollover subjects

    1. Outpatients
    2. Subjects who have completed the double-blind period of the double-blind trial and can commence the treatment period of this trial within 28 days from the completionof the double-blind period of the double-blind trial
    3. Subjects who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial
    4. Subjects with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode"
  • New subjects

    1. Outpatients
    2. Male and female patients ≥ 65 years of age (at the time of informed consent)
    3. Subjects who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial
    4. Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode" whose current episode has persisted for at least 8 weeks

Exclusion Criteria:

  • Rollover subjects

    1. Female subjects who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at baseline
    2. Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.
    3. Subjects who experience a change to the manic state in the antidepressant treatment period of the double-blind trial
    4. Subjects who are discovered to not meet the inclusion criteria or to fall under any of the exclusion criteria in the doubleblind trial
    5. Subjects who showed marked noncompliance with the IMP treatment in the double-blind trial (subjects whose IMP compliance rates are < 65% between prescribed visits)
  • New subjects

    1. Sexually active male subjects who will not agree to practice 2different methods of birth control or to remain abstinent during the trial and for 30 days after the final IMP administration. For birth control, 2 of the following methods must be used: vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.
    2. Patients with a treatment history showing that all antidepressants (also including those not used for the current major depressive episode) cannot be tolerated
    3. Patients with a history of electroconvulsive therapy
    4. Patients with a diagnosis of any of the following diseases according to DSM-5

      1. Neurocognitive disorders
      2. Schizophrenia spectrum and other psychotic disorders
      3. Bipolar and related disorders
      4. Feeding and eating disorders
      5. Obsessive-compulsive disorder
      6. Panic disorder
      7. Posttraumatic stress disorder

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 ClinicalTrials.gov identifier (NCT number): NCT03737474


Contacts
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Contact: Drug Information Center +81-3-6361-7314

Locations
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Japan
Nanko-kokorono clinic Recruiting
Shirakawa, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03737474     History of Changes
Other Study ID Numbers: 331-102-00059
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brexpiprazole
Disease
Depressive Disorder
Depression
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