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Quality of Life and Self-esteem After Botox® Injections in Depressed and Non-depressed Patients

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ClinicalTrials.gov Identifier: NCT01004042
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Quality of Life
Intervention Drug: Botulinum Toxin Type A
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Depressed Subjects Non Depressed Subjects
Hide Arm/Group Description

Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Subjects with no diagnosis of depression

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Period Title: Overall Study
Started 25 25
Completed 21 25
Not Completed 4 0
Arm/Group Title Depressed Subjects Non Depressed Subjects Total
Hide Arm/Group Description

Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Subjects with no diagnosis of depression

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
49  (7) 48  (7) 49  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
25
 100.0%
25
 100.0%
50
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Fitzpatrick Skin Phototype I Number Analyzed 25 participants 25 participants 50 participants
Phototype I
0
   0.0%
0
   0.0%
0
   0.0%
Phototype II
7
  28.0%
3
  12.0%
10
  20.0%
Phototype III
15
  60.0%
21
  84.0%
36
  72.0%
Phototype IV
2
   8.0%
1
   4.0%
3
   6.0%
Phototype V
1
   4.0%
0
   0.0%
1
   2.0%
Phototype VI
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Measure Description: Phototype I - Pale white skin, blue/green eyes, blond/red hair; Always burns, does not tan Phototype II - Fair skin, blue eyes; Burns easily, tans poorly Phototype III - Darker white skin; Tans after initial burn Phototype IV - Light brown skin; Burns minimally, tans easily Phototype V - Brown skin; Rarely burns, tans darkly easily Phototype VI - Dark brown or black skin; Never burns, always tans darkly
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Brazil Number Analyzed 25 participants 25 participants 50 participants
25
 100.0%
25
 100.0%
50
 100.0%
Marital status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Married or steady relationship
14
  56.0%
13
  52.0%
27
  54.0%
Single
3
  12.0%
4
  16.0%
7
  14.0%
Divorced
8
  32.0%
8
  32.0%
16
  32.0%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
College
11
  44.0%
9
  36.0%
20
  40.0%
College (not completed)
2
   8.0%
4
  16.0%
6
  12.0%
High School
12
  48.0%
10
  40.0%
22
  44.0%
Middle School
0
   0.0%
2
   8.0%
2
   4.0%
1.Primary Outcome
Title Rosenberg Self-Esteem Scale
Hide Description

Measure of self esteem for research purposes.

Ten questions graded from 0 to 3 as described below:

Questions 1, 3, 4, 7, 10

0 - Totally agree

  1. - Agree
  2. - Disagree
  3. - Totally disagree

Questions 2, 5, 6, 8, 9

3 - Totally agree 2 - Agree

1 - Disagree 0 - Totally disagree

The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.

Time Frame Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol.
Arm/Group Title Depressed Subjects Non Depressed Subjects
Hide Arm/Group Description:

Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Subjects with no diagnosis of depression

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 13.9  (5.3) 24.6  (4.3)
Day 1 (intervention) 13.5  (5.0) 23.3  (5.3)
Week 4 15.2  (5.8) 23.5  (4.9)
Week 8 17.1  (5.9) 24.4  (4.6)
Week 12 16.9  (6.5) 24.2  (4.9)
2.Primary Outcome
Title Beck Depression Inventory (BDI)
Hide Description

BDI is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Each question is graded from 0 to 3.

0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

Time Frame Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol.
Arm/Group Title Depressed Subjects Non Depressed Subjects
Hide Arm/Group Description:

Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Subjects with no diagnosis of depression

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 27.4  (5.2) 6.7  (5.5)
Day 1 (intervention) 24.3  (8.8) 5.8  (4.5)
Week 4 17.0  (7.9) 5.3  (4.1)
Week 8 14.9  (9.9) 4.5  (4.4)
Week 12 12.5  (7.9) 4.0  (3.4)
3.Secondary Outcome
Title WHOQOL-BREF
Hide Description

The WHOQOL-BREF is a scale for the quality of life assessment developed by the World Health Organization. It is composed by 26 questions graded from 1 to 5.

Scoring:

1 to 2.9 - needs improvement 3 to 3.9 - regular 4 to 4.9 - good 5 - very good

Question 1 asks about the individual's overall perception of quality of life. Results refer to question 1.

Time Frame Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol.
Arm/Group Title Depressed Subjects Non Depressed Subjects
Hide Arm/Group Description:

Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Subjects with no diagnosis of depression

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.9  (0.77) 3.9  (0.49)
Day 1 (intervention) 2.9  (0.85) 4.0  (0.81)
Week 4 3.6  (0.60) 4.1  (0.53)
Week 8 3.5  (0.89) 4.1  (0.57)
Week 12 3.4  (0.81) 4.1  (0.57)
4.Secondary Outcome
Title Wrinkle Severity Scale (WSS) at Rest
Hide Description

The injection of botulinum toxin type A causes muscle paralysis, reducing facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin.

The WSS is a 4-point validated scale for forehead lines:

0 - None

  1. - Mild
  2. - Moderate
  3. - Severe
Time Frame Baseline, Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Depressed Subjects Non Depressed Subjects
Hide Arm/Group Description:

Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Subjects with no diagnosis of depression

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.6  (0.76) 1.5  (0.51)
Week 4 0.4  (0.61) 0.5  (0.59)
Week 8 0.4  (0.62) 0.4  (0.58)
Week 12 0.4  (0.62) 0.7  (0.58)
5.Secondary Outcome
Title Wrinkle Severity Scale (WSS) at Maximum Contraction
Hide Description

The injection of botulinum toxin type A causes muscle paralysis, reducing facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin.

The WSS is a 4-point validated scale for forehead lines:

0 - None

  1. - Mild
  2. - Moderate
  3. - Severe
Time Frame Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol.
Arm/Group Title Depressed Subjects Non Depressed Subjects
Hide Arm/Group Description:

Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Subjects with no diagnosis of depression

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.6  (0.69) 2.7  (0.48)
Week 4 1.1  (0.64) 1.2  (0.65)
Week 8 0.9  (0.80) 1.2  (0.80)
Week 12 1.4  (0.70) 1.7  (0.56)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Depressed Subjects Non Depressed Subjects
Hide Arm/Group Description

Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Subjects with no diagnosis of depression

Botulinum Toxin Type A: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

All-Cause Mortality
Depressed Subjects Non Depressed Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Depressed Subjects Non Depressed Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Depressed Subjects Non Depressed Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      1/25 (4.00%)    
Skin and subcutaneous tissue disorders     
Edema  [1]  0/25 (0.00%)  0 1/25 (4.00%)  1
Mild eyebrow ptosis  [2]  1/25 (4.00%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Edema on the nose and infraorbital region. Patient with past history of latex allergy.
[2]
Mild ptosis in medial third of the right eyebrow
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Doris Hexsel
Organization: Brazilian Center for Studies in Dermatology
Phone: +55 51 30262633
EMail: cientifico@cbed.org.br
Layout table for additonal information
Responsible Party: Doris Hexsel, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01004042    
Other Study ID Numbers: 09-CBED09-02
First Submitted: October 28, 2009
First Posted: October 29, 2009
Results First Submitted: December 14, 2020
Results First Posted: January 26, 2021
Last Update Posted: January 26, 2021