Depressive Disorder, MajorPhase 2NCT02116361

OnabotulinumtoxinA as Treatment for Major Depressive Disorder in Adult Females

A Phase 2 study testing onabotulinumtoxinA and Normal Saline in people with Depressive Disorder, Major, run by Allergan at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females. Read more about this study

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Depressive Disorder, Major
What is being tested?: onabotulinumtoxinA and Normal Saline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 258 participants
Where: 35 sitesUnited States
Study dates: 22 Apr 2014to 22 Dec 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Moderate to severe major depressive disorder

Who cannot join

Prior treatment with botulinum toxin of any serotype for any reason
Use of antidepressant medication for depression within 2 weeks of study
Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Institute for Advanced Medical Research
Alpharetta, Georgia, 30005
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Northwest Clinical Research Center
Bellevue, Washington, 98007
CITrials
Bellflower, California, 90706
Integrative Clinical Trials
Brooklyn, New York, 11229
SPRI Clinical Trials
Brooklyn, New York, 11235
Radiant Research/Comprehensive Clinical Development, Inc.
Cerritos, California, 90703
Uptown Research Institute, LLC
Chicago, Illinois, 60640
KRK Medical Research
Dallas, Texas, 75230
Midwest Clinical Research Center
Dayton, Ohio, 45417
iResearch Atlanta, LLC
Decatur, Georgia, 30030
InSite Clinical Research
DeSoto, Texas, 75115
Sarkis Clinical Trials
Gainesville, Florida, 32607
Collaborative Neuroscience Network Inc.
Garden Grove, California, 92845
Behavioral Research Specialists, LLC
Glendale, California, 91206
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Compass Research LLC-North Clinic
Leesburg, Florida, 34748
Woodland International Research Group
Little Rock, Alaska, 72211
Clinical Neuroscience Solutions, INC
Memphis, Tennessee, 38119
Research Centers of America, LLC
Oakland Park, Florida, 33334
Excell Research, Inc.
Oceanside, California, 92056
IPS Research Company
Oklahoma City, Oklahoma, 73103
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112
NRC Research Institute
Orange, California, 92868
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
Compass Research, LLC
Orlando, Florida, 32806
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210
Zain Research LLC
Richland, Washington, 99352
Virginia Commonwealth University Clinical Research Services Unit
Richmond, Virginia, 23298
Finger Lakes Clinical Research
Rochester, New York, 14618
Artemis Institute for Clinical Research
San Diego, California, 92103
Schuster Medical Research Institute
Sherman Oaks, California, 91403
Psychiatric Medicine Associates, LLC
Skokie, Illinois, 60076
St. Louis Clinical Trials, LLC
St Louis, Missouri, 63141
Stedman Clinical Trials
Tampa, Florida, 33613

Other trials in United States

About this study

Official title: BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females

This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.

Conditions: Depressive Disorder, Major
Being tested: onabotulinumtoxinA, Normal Saline
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

onabotulinumtoxinABiological
Also called BOTOX®, botulinum toxin Type A
OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
Normal SalineDrug
Placebo (normal saline) injected into protocol-specified areas on Day 1.

Study groups in NCT02116361
Study group	Role	What they receive
Placebo for onabotulinumtoxinA 50 U	Placebo comparator	Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. Receives: Drug: Normal Saline
onabotulinumtoxinA 50 U	Experimental	OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. Receives: Biological: onabotulinumtoxinA
Placebo for onabotulinumtoxinA 30 U	Placebo comparator	Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. Receives: Drug: Normal Saline
onabotulinumtoxinA 30 U	Experimental	OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. Receives: Biological: onabotulinumtoxinA

What is being measured

The primary outcome is the main question the study is designed to answer.

Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Measured: Baseline
Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Measured: Week 6

Secondary outcomes (4)

Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Measured: Baseline
Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Measured: 24 Weeks
Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Measured: Baseline
Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 201422 Dec 2016

First posted16 Apr 2014 (estimated)
Study start22 Apr 2014
Primary completion25 Aug 2016
Study completion22 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02116361
Sponsor's protocol ID: 191622-135
Status last verified: Nov 2017
First submitted: 15 Apr 2014
Last updated: 19 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Brin MF, Durgam S, Lum A, James L, Liu J, Thase ME, Szegedi A. OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females. Int Clin Psychopharmacol. 2020 Jan;35(1):19-28. doi: 10.1097/YIC.0000000000000290.
PubMed 31609787

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Treatment for Major Depressive Disorder in Adult Females
ClinicalTrials.gov ID: NCT02116361
Acronym / sponsor ID: 191622-135
Conditions: Depressive Disorder, Major
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 22 Apr 2014 (actual)
Primary completion: 25 Aug 2016 (actual)
Study completion: 22 Dec 2016 (actual)
First posted: 16 Apr 2014 (estimated)
Results: Posted 19 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo for onabotulinumtoxinA 50 U	Placebo comparator	Drug: Normal SalinePlacebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 50 U	Experimental	Biological: onabotulinumtoxinAOnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Placebo for onabotulinumtoxinA 30 U	Placebo comparator	Drug: Normal SalinePlacebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
onabotulinumtoxinA 30 U	Experimental	Biological: onabotulinumtoxinAOnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Moderate to severe major depressive disorder

Key exclusion criteria (3 listed)

Prior treatment with botulinum toxin of any serotype for any reason
Use of antidepressant medication for depression within 2 weeks of study
Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
onabotulinumtoxinAAlso: BOTOX®, botulinum toxin Type AOnabotulinumtoxinA injected into protocol-specified areas on Day 1.	Biological	onabotulinumtoxinA 30 U, onabotulinumtoxinA 50 U
Normal SalinePlacebo (normal saline) injected into protocol-specified areas on Day 1.	Drug	Placebo for onabotulinumtoxinA 30 U, Placebo for onabotulinumtoxinA 50 U

Primary outcome

Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.
Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Week 6
The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.

4 secondary outcomes

Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
Time frame: Baseline
Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score
Time frame: 24 Weeks
Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
Time frame: Baseline
Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)
Time frame: 24 Weeks

Results and safety

Results posted to the registry on 19 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Normal Saline) for onabotulinumtoxinA 50 U	69	38
onabotulinumtoxinA 50 U	65	34
Placebo (Normal Saline) for onabotulinumtoxinA 30 U	59	33
onabotulinumtoxinA 30 U	65	34

Primary outcome: Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Time frame: Baseline. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Placebo (Normal Saline) for onabotulinumtoxinA 30 U n = 58	onabotulinumtoxinA 30 U n = 65	Placebo (Normal Saline) for onabotulinumtoxinA 50 U n = 67	onabotulinumtoxinA 50 U n = 65
Value	31.4 (3.99)	32.0 (4.12)	32.4 (5.34)	32.0 (4.44)

Population analysed: Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point

Primary outcome: Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Time frame: Week 6. Least squares mean (Standard Error). Unit: Scores on a Scale

Measure	Placebo (Normal Saline) for onabotulinumtoxinA 30 U n = 58	onabotulinumtoxinA 30 U n = 65	Placebo (Normal Saline) for onabotulinumtoxinA 50 U n = 67	onabotulinumtoxinA 50 U n = 65
Value	-7.9 (1.4)	-11.6 (1.4)	-12.9 (1.2)	-11.5 (1.2)

Population analysed: Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Normal Saline) for onabotulinumtoxinA 50 U	5 of 67 (7.5%)	21 of 67 (31.3%)	Not reported
onabotulinumtoxinA 50 U	0 of 65 (0%)	18 of 65 (27.7%)	Not reported
Placebo (Normal Saline) for onabotulinumtoxinA 30 U	1 of 58 (1.7%)	10 of 58 (17.2%)	Not reported
onabotulinumtoxinA 30 U	3 of 65 (4.6%)	21 of 65 (32.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31609787Brin MF, Durgam S, Lum A, James L, Liu J, Thase ME, Szegedi A. OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females. Int Clin Psychopharmacol. 2020 Jan;35(1):19-28. doi: 10.1097/YIC.0000000000000290.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shobhal Patel study director

Allergan

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing onabotulinumtoxinA and Normal Saline in people with Depressive Disorder, Major, run by Allergan at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02116361, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.