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

NCT ID: NCT01004042

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-04-30

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.

Conditions

Depression; Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

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.

Non Depressed subjects

Subjects with no diagnosis of depression

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

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.

Interventions

Botulinum Toxin Type A

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 Type: DRUG

Other Intervention Names

Botox®

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Brazilan Center for Studies in Dermatology

OTHER

Sponsor Role: lead

Responsible Party

Doris Hexsel

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doris M Hexsel, MD

Role: PRINCIPAL_INVESTIGATOR

Brazilian Center For Studies in Dermatology

Locations

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

09-CBED09-02

Identifier Type: -

Identifier Source: org_study_id