Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Treatment of Depression With Botulinum Type A Toxin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01392963
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Seton Healthcare Family

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: botulinum toxin type A neurotoxin complex
Drug: Placebo
Enrollment 30
Recruitment Details Participants were recruited from local outpatient psychiatry and primary care practices, and through internet advertisements and media appearances.
Pre-assignment Details A total of 101 were screened via telephone, 39 received a face-to-face screening interview, and 30 were enrolled in the study.
Arm/Group Title Botox, Then Placebo Placebo, Then Botox
Hide Arm/Group Description At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12). At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).
Period Title: Week 0 (First Intervention)
Started 11 19
Completed 11 17
Not Completed 0 2
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
Period Title: Week 12 (Second Intervention)
Started 11 17
Completed 11 17
Not Completed 0 0
Period Title: Week 24 Follow-up
Started 11 17
Completed 9 17
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
Arm/Group Title Botox, Then Placebo Placebo, Then Botox Total
Hide Arm/Group Description At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12). At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12). Total of all reporting groups
Overall Number of Baseline Participants 11 19 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 19 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
19
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 19 participants 30 participants
Female
11
 100.0%
17
  89.5%
28
  93.3%
Male
0
   0.0%
2
  10.5%
2
   6.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6
Hide Description

HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score).

PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6

Time Frame baseline and week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that completed all study visits were included in the analysis.
Arm/Group Title Placebo, Then Botox Botox, Then Placebo
Hide Arm/Group Description:

At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).

botulinum toxin type A neurotoxin complex: 29-40 U injection

Placebo: 29-40 U 0.9% NaCl injection

At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).
Overall Number of Participants Analyzed 19 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (4) -12.7  (4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Then Botox, Botox, Then Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12)
Hide Description

HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6/18 score - baseline week 0 score)

Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18.

Time Frame Baseline (Week 0), Week 6, and Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients in the placebo first group dropped out at crossover and were not included in the 18 week assessment
Arm/Group Title Placebo, Then Botox (Week 6) Placebo, Then Botox (Week 18)
Hide Arm/Group Description:
Group received placebo injection at week 0 of study followed by a Botox injection at week 12. HDRS-21 scores were done six weeks after each injection (week 6 and week 18).
Group received placebo injection at week 0 of study followed by a Botox injection at week 12. HDRS-21 scores were done six weeks after each injection (week 6 and week 18).
Overall Number of Participants Analyzed 19 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (3) -8.4  (3)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botox, Then Placebo Placebo, Then Botox
Hide Arm/Group Description At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12). At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).
All-Cause Mortality
Botox, Then Placebo Placebo, Then Botox
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Botox, Then Placebo Placebo, Then Botox
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Botox, Then Placebo Placebo, Then Botox
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/19 (0.00%) 
93% of participants were female. This did not allow for statistical analysis based on gender. Although statistically significant, the sample size of this study was small.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Katherine Sebastian
Organization: Seton Family of Hospitals
Phone: 512-324-9999 ext 89612
Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT01392963     History of Changes
Other Study ID Numbers: CR-11-021
First Submitted: July 8, 2011
First Posted: July 13, 2011
Results First Submitted: October 3, 2017
Results First Posted: July 25, 2018
Last Update Posted: July 25, 2018