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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Depression, Quality of Life

Intervention / Treatment
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* Drug: Botulinum Toxin Type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects,aged between 25 to 60 years; Subjects diagnosed as having major depression according to the criteria of DSM-IV, MINI International Neuropsychiatric Interview (MINI Brazilian version 5.0.0); 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; Subjects with mild (1), moderate (2) or severe (3) glabellar frown lines while at rest according the Severity Wrinkles Scales; Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method; Subjects who had never received botulinum toxin A previously; 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; Subjects who will be available throughout the duration of the study; Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol; Subjects with Critical appreciation preserved, attested by their assistant psychiatrist (for group1); Subjects who reside with other family members who assume co-responsibility in the study. Exclusion Criteria: 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; Pregnant or women in breastfeeding, or women planning to become pregnant Subjects with suicide risk; Subjects addicted to alcohol or illegal drugs within the last 6 months; Subjects using amino glycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers; Subjects using medications that, in the opinion of the investigator may cause depression, such as beta-blockers, oral corticosteroids and interferon; Subjects who, in the opinion of the investigator, may potentially require psychiatric hospitalization during the course of the study; Subjects with inflammation or active infection in the area to be injected; Subjects with a history of non-adherence to medical treatment, or who demonstrate unwillingness to adhere to the study protocol; The presence of any additional active DSM-IV Axis I diagnosis, or mental retardation; History of psychiatric hospitalization within the past three years.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Depressed subjects<br>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<br>* 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.<br>* Other names: Botox®;|
| Active Comparator: Non Depressed subjects<br>Subjects with no diagnosis of depression | Drug: Botulinum Toxin Type A<br>* 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.<br>* Other names: Botox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rosenberg Self-Esteem Scale | 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 - Agree - Disagree - 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) | 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 | 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 | 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 - Mild - Moderate - Severe | Baseline, Week 4, Week 8, Week 12 | 
| Wrinkle Severity Scale (WSS) at Maximum Contraction | 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 - Mild - Moderate - Severe | Baseline, Day 1 (intervention), Week 4, Week 8, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Botulinum toxin, Glabella, Quality of life, Self-steem