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

January 7, 2021 updated by: Doris Hexsel, Brazilan Center for Studies in Dermatology

Evaluation of Quality of Life and Self-esteem After Botulinum Toxin type-a (Botox®) Injections in Depressed and Non-depressed Patients

The primary objective of this study is to determine the alterations in quality of life and self-esteem after BOTOX® injections in the glabella in depressed and non-depressed patients.

The secondary objective of this study are:

  • to assess wrinkles improvement
  • to evaluate depressive symptoms using Beck Depression Inventory before and after Botox® injections.
  • to elucidate that depression is not a contraindication for botulinum toxin injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consists of two groups: one with diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0) and other without diagnosis of depression.

Subjects with depression will be part of group 1. They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Subjects with no diagnosis of depression will be part of group 2. 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.

Four visits will be scheduled. Visit 0 (baseline), Visit 1 (intervention), visit 2 (4 weeks), visit 3 (8 weeks) visit 4 (12 weeks).

The scales for the assessment of depressive symptoms, Beck Depression Inventory (BDI), will be applied at visits 1,2,3,4; WHOQOL BREF will be applied at baseline visit and 4.

Rosenberg Self-Esteem Scale will be applied in all visits. Photographs will be taken as well as the dermatological evaluation of the wrinkles and folds will be assessed using a 4-points validated Severity Wrinkles Scale, and psychiatric evaluation as well, in both groups.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90570 040
        • Brazilian Center For Studies in Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female subjects,aged between 25 to 60 years;
  2. Subjects diagnosed as having major depression according to the criteria of DSM-IV, MINI International Neuropsychiatric Interview (MINI Brazilian version 5.0.0);
  3. Subjects who are being administered a therapeutic dose of an approved, prescribed antidepressant medication (pattern doses of the literature), and have been using mentioned medication at a stable therapeutic dose for at least three months prior to the randomization visit;
  4. Subjects with mild (1), moderate (2) or severe (3) glabellar frown lines while at rest according the Severity Wrinkles Scales;
  5. Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method;
  6. Subjects who had never received botulinum toxin A previously;
  7. Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form;
  8. Subjects who will be available throughout the duration of the study;
  9. Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol;
  10. Subjects with Critical appreciation preserved, attested by their assistant psychiatrist (for group1);
  11. Subjects who reside with other family members who assume co-responsibility in the study.

Exclusion Criteria:

  1. Subjects whose medical history and physical examination present clinical pathology, as myasthenia gravis, Eaton-Lambert Syndrome, neoplasm, muscular diseases, motor neuron diseases, systemic autoimmune or neurological diseases;
  2. Pregnant or women in breastfeeding, or women planning to become pregnant
  3. Subjects with suicide risk;
  4. Subjects addicted to alcohol or illegal drugs within the last 6 months;
  5. Subjects using amino glycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers;
  6. Subjects using medications that, in the opinion of the investigator may cause depression, such as beta-blockers, oral corticosteroids and interferon;
  7. Subjects who, in the opinion of the investigator, may potentially require psychiatric hospitalization during the course of the study;
  8. Subjects with inflammation or active infection in the area to be injected;
  9. Subjects with a history of non-adherence to medical treatment, or who demonstrate unwillingness to adhere to the study protocol;
  10. The presence of any additional active DSM-IV Axis I diagnosis, or mental retardation;
  11. History of psychiatric hospitalization within the past three years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Depressed subjects
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.
Drug: 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.
Other Names:
  • Botox®
Active Comparator: Non Depressed subjects
Subjects with no diagnosis of depression
Drug: 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.
Other Names:
  • Botox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rosenberg Self-Esteem Scale
Time Frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

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.
Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Beck Depression Inventory (BDI)
Time Frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

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.
Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHOQOL-BREF
Time Frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

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.
Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Wrinkle Severity Scale (WSS) at Rest
Time Frame: Baseline, Week 4, Week 8, Week 12

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
Baseline, Week 4, Week 8, Week 12
Wrinkle Severity Scale (WSS) at Maximum Contraction
Time Frame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

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
Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brazilan Center for Studies in Dermatology

Collaborators

Allergan

Investigators

  • Principal Investigator: Doris M Hexsel, MD, Brazilian Center For Studies in Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-CBED09-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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