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Evaluation of Quality of Life and Self-steem After Botox® in Depressed and Non-depressed Patients

2014-08-27 03:18:21 | BioPortfolio

Summary

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

The secondary objective of this study are:

- to elaborate a description of the muscles involved in the Veraguth Fold

- 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.

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 Design

Allocation: Non-Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Depression

Intervention

Botulinum Toxin Type A - BOTOX

Location

Brazilian Center for Studies in Dermatology
Porto Alegre
Rio Grande do Sul
Brazil
90570 040

Status

Recruiting

Source

Brazilan Center for Studies in Dermatology

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:21-0400

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