Evaluation of Quality of Life and Self-steem After Botox® in Depressed and Non-depressed Patients

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT01004042
First received: October 28, 2009
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

The primary objective of this study is to determine the alterations in quality of life and self-steem after BOTOX® injections in the glabella in depressed and non-depressed patients.

The secondary objective of this study are:

  • to elaborate a description of the muscles involved in the Veraguth Fold
  • 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.

Condition Intervention Phase
Depression
Quality of Life
Drug: Botulinum Toxin Type A - BOTOX
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Quality of Life and Self-steem After Botulinum Toxin type-a (Botox®) Injections in Depressed and Non-depressed Patients

Resource links provided by NLM:


Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:
  • WHOQOL BREF [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rosenberg Self-Esteem Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Botulinum Toxin Type A - BOTOX
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.
Active Comparator: Non Depressed subjects
Subjects with no diagnosis of depression
Drug: Botulinum Toxin Type A - BOTOX
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.

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

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004042

Locations
Brazil
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil, 90570 040
Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Allergan
Investigators
Principal Investigator: Doris M Hexsel, MD Brazilian Center For Studies in Dermatology
  More Information

No publications provided

Responsible Party: Doris Hexsel, MD, Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier: NCT01004042     History of Changes
Other Study ID Numbers: 09-CBED09-02, Version 2.0: 10/07/2009
Study First Received: October 28, 2009
Last Updated: February 28, 2012
Health Authority: Brazil: Ministry of Health

Keywords provided by Brazilan Center for Studies in Dermatology:
Depression
Botulinum toxin
Glabella
Quality of life
Self-steem

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014