Depression
Conditions
Keywords
botox, depression
Brief summary
A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psychiatrist at every visit who will assess their depression.
Detailed description
Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead
Interventions
DRUGbotulinum toxin type A neurotoxin complex
29-40 U injection
DRUGPlacebo
29-40 U 0.9% NaCl injection
Sponsors
Seton Healthcare Family
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male/Female between the ages of 18 and 65 2. Major Depression Disorder as defined by DSM IV criteria and diagnosed by a psychiatrist. DSM (Diagnostic and Statistical Manual) IV criteria for depression are: a depressed mood or anhedonia for at least a two week period. This mood must represent a change from the person's normal mood; social, occupational, educational or other important functioning must also be negatively impaired by the change in mood. Major depressive disorder cannot be diagnosed if a person has a history of bipolar disorder or if the depressed mood is better accounted for by substance abuse or a psychotic disorder. In addition, the patient must have 5 of the following symptoms: * Significant weight loss or weight gain. * Insomnia or hypersomnia * Psychomotor agitation or retardation * Feelings of worthlessness or excessive guilt * Poor Concentration * Fatigue or loss of energy * Suicidal thoughts 3. History of depression for at least 6 months 4. Initial score 14 or higher on initial Hamilton Depression rating scale. 5. Melancholic facial expressions amenable to treatment with Botox. Photos will be taken of potential participants and ranked independently by two investigators, on a scale of 1-10 based on how negative they look, 10 being the highest. Patients with an average score of 6 or above will be included in the study
Exclusion criteria
1. Active substance abuse 2. Bipolar Depression 3. Subjects who are pregnant, nursing or trying to become pregnant during study participation 4. Subjects who are currently on more than 3 psychiatric medications at the time of enrollment 5. Current medications used to treat depression must be stable for at least 60 days prior to enrollment 6. Previous Botox treatment 7. The Principle Investigator has determined that this study is not in the best interest of the subject and therefore the subject will not be enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6 | baseline and week 6 | HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score). PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12) | Baseline (Week 0), Week 6, and Week 18 | HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6/18 score - baseline week 0 score) Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from local outpatient psychiatry and primary care practices, and through internet advertisements and media appearances.
Pre-assignment details
A total of 101 were screened via telephone, 39 received a face-to-face screening interview, and 30 were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Botox, Then Placebo At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12). | 11 |
| Placebo, Then Botox At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12). | 19 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Week 0 (First Intervention) | Lost to Follow-up | 0 | 1 |
| Week 0 (First Intervention) | Withdrawal by Subject | 0 | 1 |
| Week 24 Follow-up | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Botox, Then Placebo | Placebo, Then Botox | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 19 Participants | 30 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 11 Participants | 17 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 19 |
| other Total, other adverse events | 0 / 11 | 0 / 19 |
| serious Total, serious adverse events | 0 / 11 | 0 / 19 |
Outcome results
Primary
Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6
HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score). PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6
Time frame: baseline and week 6
Population: Participants that completed all study visits were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Botox | Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6 | -0.4 units on a scale | Standard Deviation 4 |
| Botox, Then Placebo | Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6 | -12.7 units on a scale | Standard Deviation 4 |
p-value: 0.001Mixed Models Analysis
Secondary
Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12)
HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6/18 score - baseline week 0 score) Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18.
Time frame: Baseline (Week 0), Week 6, and Week 18
Population: 2 patients in the placebo first group dropped out at crossover and were not included in the 18 week assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo, Then Botox | Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12) | -0.4 units on a scale | Standard Deviation 3 |
| Botox, Then Placebo | Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12) | -8.4 units on a scale | Standard Deviation 3 |