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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brazilan Center for Studies in Dermatology
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.