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

Phase 4

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Depressed subjects	Botulinum Toxin Type A	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.
Non Depressed subjects	Botulinum Toxin Type A	Subjects with no diagnosis of depression

Primary Outcome Measures

Name	Time	Method
Rosenberg Self-Esteem Scale	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.
Beck Depression Inventory (BDI)	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.

Secondary Outcome Measures

Name	Time	Method
WHOQOL-BREF	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.
Wrinkle Severity Scale (WSS) at Rest	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
Wrinkle Severity Scale (WSS) at Maximum Contraction	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