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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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Brexpiprazole
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brexpiprazole and ADT
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Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Period Title: Overall Study
Started 26
Completed 0
Not Completed 26
Reason Not Completed
Adverse Event             1
Lack of Efficacy             1
Non-compliance with IMP             1
Administrative or other reasons             23
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  11.5%
>=65 years
23
  88.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
66.12  (10.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
21
  80.8%
Male
5
  19.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
United States 14
Slovakia 2
Sweden 2
United Kingdom 1
Estonia 3
Finland 2
Germany 2
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events
Hide Description Number of participants with Treatment-Emergent Adverse Events
Time Frame From baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description:

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
28
2.Primary Outcome
Title Number of Withdrawals
Hide Description Number of withdrawals
Time Frame From baseline to Week 52
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Hide Analysis Population Description
26 patients were withdrawn; the reason for withdrawal was not poor tolerability, but mainly (23 patients) because the study was terminated. Please see withdrawn reasons in the participant flow section for the other reasons.
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description:

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
26
3.Secondary Outcome
Title Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Hide Description 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.
Time Frame From baseline to Week 52
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Hide Analysis Population Description
all-patients treated set (APTS)
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description:

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
No suicidal ideation or behaviour 25
Any non-suicidal self-injurious behavior 0
Suicidal Ideation 1
Preparatory action towards imminent suicidal 0
Not fatal suicide attempt 0
Completed suicide 0
4.Secondary Outcome
Title Change in Depressive Symptoms
Hide Description The Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Time Frame From baseline to Week 52
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Hide Analysis Population Description
None of the patients completed the study. A total of 26 patients were enrolled when the study was prematurely terminated(Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description:

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

Brexpiprazole: 1,2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Proportion of Patients in Remission
Hide Description Based on a pre-specified MADRS total score
Time Frame From baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description:

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Clinical Global Impression
Hide Description Clinical Global Impression - Severity of illness (CGI-S) score
Time Frame From baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description:

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in Health-related Quality of Life
Hide Description Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score
Time Frame From baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description:

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Change in Health-related Quality of Life
Hide Description 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).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
Arm/Group Title Brexpiprazole
Hide Arm/Group Description:

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From baseline to Week 52
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brexpiprazole and ADT
Hide Arm/Group Description

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

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

All-Cause Mortality
Brexpiprazole and ADT
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brexpiprazole and ADT
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brexpiprazole and ADT
Affected / at Risk (%)
Total   5/26 (19.23%) 
Injury, poisoning and procedural complications   
Accidental overdose  1  3/26 (11.54%) 
Nervous system disorders   
Lethargy  1  2/26 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: H. Lundbeck A/S
Organization: H. Lundbeck A/S
Phone: +45 36301311
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01944969     History of Changes
Other Study ID Numbers: 14767B
2012-004169-42 ( EudraCT Number )
First Submitted: September 13, 2013
First Posted: September 18, 2013
Results First Submitted: August 17, 2015
Results First Posted: March 3, 2016
Last Update Posted: October 17, 2018