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Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment

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ClinicalTrials.gov Identifier: NCT02400346
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : June 26, 2017
Last Update Posted : August 10, 2017
Sponsor:
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 Depression Disorder
Interventions Drug: Adjunct brexpiprazole
Drug: ADT
Enrollment 132
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adjunct Brexpiprazole
Hide Arm/Group Description

All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.

Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.

Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.

Period Title: Overall Study
Started 132
Completed 88
Not Completed 44
Reason Not Completed
Adverse Event             24
Lack of Efficacy             9
Non-compliance with IMP             1
Withdrawal by Subject             7
Administrative or other reason(s)             2
Lost to Follow-up             1
Arm/Group Title Adjunct Brexpiprazole
Hide Arm/Group Description

All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.

Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.

Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.

Overall Number of Baseline Participants 132
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants
71.4  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Female
107
  81.1%
Male
25
  18.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   1.5%
White
130
  98.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
United States
52
  39.4%
Finland
27
  20.5%
Poland
17
  12.9%
Germany
15
  11.4%
Estonia
21
  15.9%
1.Primary Outcome
Title Number of Patients With Treatment-Emergent Adverse Events
Hide Description Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
Time Frame Baseline to 30 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adjunct Brexpiprazole
Hide Arm/Group Description:

All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.

Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.

Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.

Overall Number of Participants Analyzed 132
Measure Type: Count of Participants
Unit of Measure: Participants
102
  77.3%
Time Frame Baseline to end of study (30 weeks)
Adverse Event Reporting Description Treatment-Emergent Adverse Events are reported in this section
 
Arm/Group Title Brex + ADT
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Brex + ADT
Affected / at Risk (%)
Total   1/132 (0.76%) 
Show Serious Adverse Events Hide Serious Adverse Events
Brex + ADT
Affected / at Risk (%)
Total   6/132 (4.55%) 
Cardiac disorders   
Acute myocardial infarction  1  1/132 (0.76%) 
Myocardial rupture  1  1/132 (0.76%) 
Infections and infestations   
Postoperative wound infection  1  1/132 (0.76%) 
Injury, poisoning and procedural complications   
Eye contusion  1  1/132 (0.76%) 
Facial bones fracture  1  1/132 (0.76%) 
Fall  1  1/132 (0.76%) 
Nervous system disorders   
Transient ischaemic attack  1  1/132 (0.76%) 
Psychiatric disorders   
Depression  1  1/132 (0.76%) 
Major depression  1  1/132 (0.76%) 
Panic attack  1  1/132 (0.76%) 
Vascular disorders   
Hypotension  1  1/132 (0.76%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brex + ADT
Affected / at Risk (%)
Total   79/132 (59.85%) 
General disorders   
Fatigue  1  20/132 (15.15%) 
Infections and infestations   
Nasopharyngitis  1  8/132 (6.06%) 
Investigations   
Weight increased  1  11/132 (8.33%) 
Metabolism and nutrition disorders   
Increased appetite  1  13/132 (9.85%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  7/132 (5.30%) 
Nervous system disorders   
Akathisia  1  11/132 (8.33%) 
Dizziness  1  10/132 (7.58%) 
Headache  1  7/132 (5.30%) 
Tremor  1  9/132 (6.82%) 
Psychiatric disorders   
Anxiety  1  10/132 (7.58%) 
Insomnia  1  8/132 (6.06%) 
Restlessness  1  17/132 (12.88%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Email contact via
Organization: H. Lundbeck A/S
EMail: LundbeckClinicalTrials@Lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02400346     History of Changes
Other Study ID Numbers: 16160A
2014-003547-35 ( EudraCT Number )
First Submitted: March 17, 2015
First Posted: March 27, 2015
Results First Submitted: June 2, 2017
Results First Posted: June 26, 2017
Last Update Posted: August 10, 2017