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Trial Outcomes & Findings for The Treatment of Depression With Botulinum Type A Toxin (NCT NCT01392963)

NCT ID: NCT01392963

Last Updated: 2018-07-26

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

baseline and week 6

Results posted on

2018-07-26

Participant Flow

Participants were recruited from local outpatient psychiatry and primary care practices, and through internet advertisements and media appearances.

A total of 101 were screened via telephone, 39 received a face-to-face screening interview, and 30 were enrolled in the study.

Participant milestones

Participant milestones
Measure
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).
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).
Week 0 (First Intervention)
STARTED
11
19
Week 0 (First Intervention)
COMPLETED
11
17
Week 0 (First Intervention)
NOT COMPLETED
0
2
Week 12 (Second Intervention)
STARTED
11
17
Week 12 (Second Intervention)
COMPLETED
11
17
Week 12 (Second Intervention)
NOT COMPLETED
0
0
Week 24 Follow-up
STARTED
11
17
Week 24 Follow-up
COMPLETED
9
17
Week 24 Follow-up
NOT COMPLETED
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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).
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).
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

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Botox, Then Placebo
n=11 Participants
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).
Placebo, Then Botox
n=19 Participants
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).
Total
n=30 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=11 Participants
0 Participants
n=19 Participants
0 Participants
n=30 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=11 Participants
19 Participants
n=19 Participants
30 Participants
n=30 Participants
Age, Categorical
>=65 years
0 Participants
n=11 Participants
0 Participants
n=19 Participants
0 Participants
n=30 Participants
Sex: Female, Male
Female
11 Participants
n=11 Participants
17 Participants
n=19 Participants
28 Participants
n=30 Participants
Sex: Female, Male
Male
0 Participants
n=11 Participants
2 Participants
n=19 Participants
2 Participants
n=30 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: baseline and week 6

Population: Participants that completed all study visits were included in the analysis.

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

Outcome measures

Outcome measures
Measure
Placebo, Then Botox
n=19 Participants
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). botulinum toxin type A neurotoxin complex: 29-40 U injection Placebo: 29-40 U 0.9% NaCl injection
Botox, Then Placebo
n=11 Participants
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. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).
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
-12.7 units on a scale
Standard Deviation 4

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
Placebo, Then Botox
n=19 Participants
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). botulinum toxin type A neurotoxin complex: 29-40 U injection Placebo: 29-40 U 0.9% NaCl injection
Botox, Then Placebo
n=17 Participants
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. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).
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
-8.4 units on a scale
Standard Deviation 3

Adverse Events

Botox, Then Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo, Then Botox

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Sebastian

Seton Family of Hospitals

Phone: 512-324-9999

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place