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

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.