Evaluation of Quality of Life and Self-esteem After Botulinum Toxin type-a (Botox®) Injections in Depressed and Non-depressed Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rosenberg Self-Esteem Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Depressed subjects
Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.
干预措施: Botulinum Toxin Type A (Drug)
Non Depressed subjects
Subjects with no diagnosis of depression
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Rosenberg Self-Esteem Scale
时间窗: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
Measure of self esteem for research purposes. Ten questions graded from 0 to 3 as described below: Questions 1, 3, 4, 7, 10 0 - Totally agree 1. - Agree 2. - Disagree 3. - Totally disagree Questions 2, 5, 6, 8, 9 3 - Totally agree 2 - Agree 1 - Disagree 0 - Totally disagree The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Beck Depression Inventory (BDI)
时间窗: Baseline, Day 1 (intervention), Week 4, Week 8, Week 12
BDI is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Each question is graded from 0 to 3. 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
次要结局
- WHOQOL-BREF(Baseline, Day 1 (intervention), Week 4, Week 8, Week 12)
- Wrinkle Severity Scale (WSS) at Rest(Baseline, Week 4, Week 8, Week 12)
- Wrinkle Severity Scale (WSS) at Maximum Contraction(Baseline, Day 1 (intervention), Week 4, Week 8, Week 12)
研究者
Doris Hexsel
MD
Brazilan Center for Studies in Dermatology