Quality of Life and Self-esteem After Botox® Injections in Depressed and Non-depressed Patients
Condition: Depression; Quality of Life
MeSH terms: Depression
Intervention: Botulinum Toxin Type A
Intervention description: 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.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 25 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Depression; Botulinum toxin; Glabella; Quality of life; Self-steem

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.
    

Eligibility criteria:

        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.