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

NCT01004042 | Completed Phase 4 Results

• 1 other identifier: 09-CBED09-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Quality of Life

Keywords

Depression; Botulinum toxin; Glabella; Quality of life; Self-steem

Outcome Measures

Primary Outcomes (2)

• Rosenberg Self-Esteem Scale

  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.

  Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

• Beck Depression Inventory (BDI)

  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.

  Baseline, Day 1 (intervention), Week 4, Week 8, Week 12

Secondary Outcomes (3)

• 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

Study Arms (2)

Depressed subjects

ACTIVE COMPARATOR

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.

Drug: Botulinum Toxin Type A

Non Depressed subjects

ACTIVE COMPARATOR

Subjects with no diagnosis of depression

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A 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.

Also known as: Botox®

Depressed subjects; Non Depressed subjects

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hexsel Dermatology Clinic: lead
• Allergan: collaborator

Study Sites (1)

Brazilian Center for Studies in Dermatology

Porto Alegre, Rio Grande do Sul, 90570 040, Brazil

Location

MeSH Terms

Conditions

Depression

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Doris Hexsel
• Organization: Brazilian Center for Studies in Dermatology

cientifico@cbed.org.br

+55 51 30262633

Study Officials

• Doris M Hexsel, MD

  Brazilian Center For Studies in Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Locations

BR (1)