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OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

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ClinicalTrials.gov Identifier: NCT02116361
Recruitment Status : Completed
First Posted : April 16, 2014
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Interventions Biological: onabotulinumtoxinA
Drug: Normal Saline
Enrollment 258
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U
Hide Arm/Group Description Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Period Title: Overall Study
Started 69 65 59 65
Completed 38 34 33 34
Not Completed 31 31 26 31
Reason Not Completed
Pregnancy             0             0             0             1
Protocol Violation             1             0             0             2
Physician Decision             2             3             0             0
Adverse Event             1             0             0             3
Other Reasons             3             3             3             3
Lack of Efficacy             5             7             4             3
Lost to Follow-up             4             5             7             5
Personal Reasons             6             6             4             9
Investigator Decision - Relapse             9             7             8             5
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U Total
Hide Arm/Group Description Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 67 65 58 65 255
Hide Baseline Analysis Population Description
Modified Intent to Treat: Enrolled subjects who received treatment
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 67 participants 65 participants 58 participants 65 participants 255 participants
<40 years 26 21 21 26 94
≥ 40 years 41 44 37 39 161
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 65 participants 58 participants 65 participants 255 participants
Female
67
 100.0%
65
 100.0%
58
 100.0%
65
 100.0%
255
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U
Hide Arm/Group Description:
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Overall Number of Participants Analyzed 58 65 67 65
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
31.4  (3.99) 32.0  (4.12) 32.4  (5.34) 32.0  (4.44)
2.Primary Outcome
Title Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide Description The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U
Hide Arm/Group Description:
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Overall Number of Participants Analyzed 58 65 67 65
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
-7.9  (1.4) -11.6  (1.4) -12.9  (1.2) -11.5  (1.2)
3.Secondary Outcome
Title Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
Hide Description The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U
Hide Arm/Group Description:
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Overall Number of Participants Analyzed 58 65 67 65
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
4.2  (0.43) 4.4  (0.53) 4.4  (0.53) 4.5  (0.50)
4.Secondary Outcome
Title Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
Hide Description The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U
Hide Arm/Group Description:
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Overall Number of Participants Analyzed 33 36 38 34
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
-1.4  (0.2) -1.9  (0.2) -2.6  (0.2) -2.9  (0.2)
5.Secondary Outcome
Title Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
Hide Description The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U
Hide Arm/Group Description:
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Overall Number of Participants Analyzed 58 65 67 65
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
23.7  (3.15) 24.5  (3.03) 23.3  (2.94) 23.0  (3.32)
6.Secondary Outcome
Title Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
Hide Description The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U
Hide Arm/Group Description:
Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Overall Number of Participants Analyzed 33 36 38 34
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
-11.5  (1.1) -13.4  (1.1) -16.1  (0.8) -17.4  (0.8)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
 
Arm/Group Title Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U
Hide Arm/Group Description Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
All-Cause Mortality
Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/67 (7.46%)   0/65 (0.00%)   1/58 (1.72%)   3/65 (4.62%) 
General disorders         
Sudden Death  1  0/67 (0.00%)  0/65 (0.00%)  0/58 (0.00%)  1/65 (1.54%) 
Injury, poisoning and procedural complications         
Fibula Fracture  1  1/67 (1.49%)  0/65 (0.00%)  0/58 (0.00%)  0/65 (0.00%) 
Foot Fracture  1  1/67 (1.49%)  0/65 (0.00%)  0/58 (0.00%)  0/65 (0.00%) 
Ligament Rupture  1  1/67 (1.49%)  0/65 (0.00%)  0/58 (0.00%)  0/65 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign Breast Neoplasm  1  0/67 (0.00%)  0/65 (0.00%)  1/58 (1.72%)  0/65 (0.00%) 
Nervous system disorders         
Cerebrovascular Accident  1  0/67 (0.00%)  0/65 (0.00%)  0/58 (0.00%)  1/65 (1.54%) 
Psychiatric disorders         
Hallucination, Auditory * 1  1/67 (1.49%)  0/65 (0.00%)  0/58 (0.00%)  0/65 (0.00%) 
Suicidal Ideation * 1  1/67 (1.49%)  0/65 (0.00%)  0/58 (0.00%)  1/65 (1.54%) 
Vascular disorders         
Varicose Vein * 1  1/67 (1.49%)  0/65 (0.00%)  0/58 (0.00%)  0/65 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Normal Saline) for onabotulinumtoxinA 50 U onabotulinumtoxinA 50 U Placebo (Normal Saline) for onabotulinumtoxinA 30 U onabotulinumtoxinA 30 U
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/67 (31.34%)   18/65 (27.69%)   10/58 (17.24%)   21/65 (32.31%) 
Eye disorders         
Eyelid Ptosis * 1  0/67 (0.00%)  2/65 (3.08%)  0/58 (0.00%)  4/65 (6.15%) 
Infections and infestations         
Sinusitis  1  0/67 (0.00%)  0/65 (0.00%)  4/58 (6.90%)  4/65 (6.15%) 
URI  1  3/67 (4.48%)  4/65 (6.15%)  1/58 (1.72%)  3/65 (4.62%) 
Nasopharyngitis * 1  6/67 (8.96%)  3/65 (4.62%)  3/58 (5.17%)  2/65 (3.08%) 
Nervous system disorders         
Headache * 1  15/67 (22.39%)  11/65 (16.92%)  4/58 (6.90%)  9/65 (13.85%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 19.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Arlene Lum, PMP
Organization: Allergan, Inc
Phone: 714-246-5548
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02116361     History of Changes
Other Study ID Numbers: 191622-135
First Submitted: April 15, 2014
First Posted: April 16, 2014
Results First Submitted: November 21, 2017
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017