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Trial record 49 of 1857 for:    "Depressive Disorder" [DISEASE] | "Depressive Disorder, Major"

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo (Normal Saline) for onabotulinumtoxinA 50 U Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 50 U OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Placebo (Normal Saline) for onabotulinumtoxinA 30 U Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 30 U OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

Participant Flow:   Overall Study
    Placebo (Normal Saline) for onabotulinumtoxinA 50 U   onabotulinumtoxinA 50 U   Placebo (Normal Saline) for onabotulinumtoxinA 30 U   onabotulinumtoxinA 30 U
STARTED   69   65   59   65 
COMPLETED   38   34   33   34 
NOT COMPLETED   31   31   26   31 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent to Treat: Enrolled subjects who received treatment

Reporting Groups
  Description
Placebo (Normal Saline) for onabotulinumtoxinA 50 U Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 50 U OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Placebo (Normal Saline) for onabotulinumtoxinA 30 U Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 30 U OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Total Total of all reporting groups

Baseline Measures
   Placebo (Normal Saline) for onabotulinumtoxinA 50 U   onabotulinumtoxinA 50 U   Placebo (Normal Saline) for onabotulinumtoxinA 30 U   onabotulinumtoxinA 30 U   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   65   58   65   255 
Age, Customized 
[Units: Participants]
         
<40 years   26   21   21   26   94 
≥ 40 years   41   44   37   39   161 
Sex: Female, Male 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline ]

2.  Primary:   Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Week 6 ]

3.  Secondary:   Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score   [ Time Frame: Baseline ]

4.  Secondary:   Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score   [ Time Frame: 24 Weeks ]

5.  Secondary:   Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)   [ Time Frame: Baseline ]

6.  Secondary:   Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)   [ Time Frame: 24 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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 more than 60 days but less than or equal to 180 days. 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
e-mail: lum_arlene@allergan.com



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