Clinical trial NCT01004042: Quality of Life and Self-esteem After Botox® Injections in Depressed and Non-depressed Patients
Official title: Evaluation of Quality of Life and Self-esteem After Botulinum Toxin type-a (Botox®) Injections in Depressed and Non-depressed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Quality of Life
Keywords: Depression
Botulinum toxin
Glabella
Quality of life
Self-steem
Lead sponsor: Brazilan Center for Studies in Dermatology
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2009-10-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rosenberg Self-Esteem Scale
timeFrame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Secondary outcomes:
measure: WHOQOL-BREF
timeFrame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
measure: Wrinkle Severity Scale (WSS) at Rest
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Wrinkle Severity Scale (WSS) at Maximum Contraction
timeFrame: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Brazilian Center for Studies in Dermatology
state: Rio Grande Do Sul
Study officials:
affiliation: Brazilian Center For Studies in Dermatology
name: Doris M Hexsel, MD
role: PRINCIPAL_INVESTIGATOR
References: