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Trial record 4 of 65 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.

Tracking Information
First Submitted Date  ICMJE July 29, 2018
First Posted Date  ICMJE November 9, 2018
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE October 4, 2018
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03737474 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder
Official Title  ICMJE 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
Brief Summary This trial is a 52-week safety study to evaluate the safety of adjunctive Brexpiprazole in outpatients with major depressive disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Brexpiprazole
2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily
Study Arms  ICMJE Experimental: Brexpiprazole
2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily
Intervention: Drug: Brexpiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Drug Information Center +81-3-6361-7314
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03737474
Other Study ID Numbers  ICMJE 331-102-00059
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP