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Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Troriluzole
Placebo
Sponsored by
Biohaven Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder (OCD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at screening; the duration of the subjects illness must be ≥ 1year
  2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response too current standard of car base on the YBOCS score.
  3. Determined by the investigator to be medically stable at baseline/ randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trail as designed.

Key Exclusion Criteria:

  1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD.
  2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results.
  3. Previous treatment in a study with troriluzole

Sites / Locations

  • Alea ResearchRecruiting
  • ProScience Research Group
  • Sun Valley Research Center, Inc.
  • Kaizen Brain CenterRecruiting
  • Om Research LLCRecruiting
  • ASCLEPES ResearchCEnters, P.C.
  • CalNeuro Research GroupRecruiting
  • North County Clinical Research
  • CI Trials
  • Lumos Clinical Research Center, LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • California Neuroscience Research Medical Group, Inc.Recruiting
  • Pacific Clinical Research Medical GroupRecruiting
  • Mountain View Clinical ResearchRecruiting
  • Institute of Living / Hartford Hospital
  • Comprehensive Psychiatric CareRecruiting
  • Topaz Clinical ResearchRecruiting
  • CNS Research of Coral SpringsRecruiting
  • Gulfcoast Clinical Research CenterRecruiting
  • University of Florida Department of Psychiatry
  • Qway Research, LLC
  • Clinical Neuroscience Solutions, Inc.Recruiting
  • Clintex Research
  • Med-Care ResearchRecruiting
  • Ezy Medical Research, Co.
  • Miami Dade Medical Research Institute
  • Advanced Research for Health Improvement
  • Bravo Health Care Center
  • Harmony Clinical ResearchRecruiting
  • dTMS Center LLCRecruiting
  • DMI ResearchRecruiting
  • Olympian Clinical Research
  • CenExel iResearchRecruiting
  • Renew Health Clinical Research, LLC
  • University of Chicago Department of Psychiatry & Behavioral NeuroscienceRecruiting
  • AMR-Baber Research, Inc.Recruiting
  • Collective Medical ResearchRecruiting
  • Riverstar Research
  • Continental Clinical Solutions, LLCRecruiting
  • Boston Clinical TrialsRecruiting
  • Adams Clinical
  • Psychiatric Care and Research CenterRecruiting
  • Boeson Research
  • Center for Emotional Fitness
  • SPRI Clinical Trials, LLCRecruiting
  • Manhattan Behavioral Medicine, PLLCRecruiting
  • Finger Lakes Clinical Research
  • ARSMNC
  • Richard H. Weisler, MD PA & AssociatesRecruiting
  • CTI Clinical Research Center
  • American Clinical Research Institute (ACRI)Recruiting
  • Neurology Diagnostics, Inc.
  • American Research Institute (ACRI)Recruiting
  • North Star Medical Research, LLCRecruiting
  • IPS Research
  • Lehigh Center for Clinical ResearchRecruiting
  • Suburban Research AssociatesRecruiting
  • Coastal Carolina Research Center
  • Donald J. Garcia Jr., MD PARecruiting
  • Inquest Clinical ResearchRecruiting
  • FutureSearch Trials of Dallas, LPRecruiting
  • InSite Clinical ResearchRecruiting
  • NovoTrial Research Group
  • Clinical Trial NetworkRecruiting
  • AIM TrialsRecruiting
  • Clinical Trials of Texas, Inc.
  • Woodstock Research CenterRecruiting
  • University of CalgaryRecruiting
  • Chatham-Kent Clinical Trials Research CentreRecruiting
  • McMaster University, Hamilton Health SciencesRecruiting
  • Queen's UniversityRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • START Clinic for Mood and Anxiety DisordersRecruiting
  • University of Toronto / Centre for Addiction and Mental Health (CAMH)Recruiting
  • Beijing HuiLongGuan HospitalRecruiting
  • Peking University Sixth HospitalRecruiting
  • Hangzhou Seventh People's HospitalRecruiting
  • Tianjin Anding HospitalRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Nanjing Brain HospitalRecruiting
  • Shanghai Mental Health CenterRecruiting
  • Wuhan Mental Health CenterRecruiting
  • The First Affiliated Hospital of Jinan UniversityRecruiting
  • Mental Health Center, West China Hospital, Sichuan UniversityRecruiting
  • First Hospital of Hebei Medical UniversityRecruiting
  • Institute of Neuroscience, University of Firenze
  • ASST FBF SACCO - Ospedale Universitario Luigi SaccoRecruiting
  • University School of Medicine of Napoli Federico IIRecruiting
  • University of PisaRecruiting
  • University of Turin - university hospital san luigi gonzagaRecruiting
  • Amsterdam UMC, locatie AMCRecruiting
  • Leiden University Medical Center (LUMC)Recruiting
  • Barbara Diaz Hernandez MD Research, Inc.
  • Hospital Universitario de BellvitgeRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Clínico San Carlos
  • Centro de Salud Mental La CorredoriaRecruiting
  • Centro de Salud San JuanRecruiting
  • Hospital Álvaro CunqueiroRecruiting
  • MAC Clinical ResearchRecruiting
  • Stemax Consult - Healthcare Services LtdRecruiting
  • MAC Clinical Research - South StaffordshireRecruiting
  • MAC Clinical Research-LancashireRecruiting
  • Surrey and Borders Partnership NHS Foundation Trust
  • MAC Clinical ResearchRecruiting
  • MAC Clinical Research -- MerseysideRecruiting
  • South West London and St George's Mental Health NHS Trust Springfield University Hospital
  • Greater Manchester Mental Health NHS Foundation TrustRecruiting
  • Bioluminux LtdRecruiting
  • Kingshill Research CentreRecruiting
  • MAC Clinical Research-- South YorkshireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Troriluzole

Placebo

Arm Description

Troriluzole- 2 100mg capsules once daily for the first two weeks. Troriluzole- 2 140mg capsules once daily from week two through week ten.

Placebo- 2 100mg capsules once daily for the first two weeks. Placebo- 2 140mg capsules once daily from week two through week ten.

Outcomes

Primary Outcome Measures

The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS)
Improvement is measured by a lower total score

Secondary Outcome Measures

Frequency of SAEs and AEs leading discontinuation
Percent difference between troriluzole vs placebo treatment emergent adverse events
Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)
Change is measured as "mild" or "moderate" on the SDS
Improvement in global functioning responses as assessed on the CGI-I scale.
Change is measured as "much improved" or very much improved" on the CGI-I scale.

Full Information

First Posted
December 30, 2020
Last Updated
August 22, 2023
Sponsor
Biohaven Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04693351
Brief Title
Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder
Official Title
A Randomized, Double-Blind, Placebo- Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biohaven Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study's purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder (OCD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Troriluzole
Arm Type
Experimental
Arm Description
Troriluzole- 2 100mg capsules once daily for the first two weeks. Troriluzole- 2 140mg capsules once daily from week two through week ten.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo- 2 100mg capsules once daily for the first two weeks. Placebo- 2 140mg capsules once daily from week two through week ten.
Intervention Type
Drug
Intervention Name(s)
Troriluzole
Intervention Description
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.
Primary Outcome Measure Information:
Title
The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS)
Description
Improvement is measured by a lower total score
Time Frame
Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10
Secondary Outcome Measure Information:
Title
Frequency of SAEs and AEs leading discontinuation
Description
Percent difference between troriluzole vs placebo treatment emergent adverse events
Time Frame
From Screening through Study completion, up to 10 weeks
Title
Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)
Description
Change is measured as "mild" or "moderate" on the SDS
Time Frame
From baseline through study completion (up to 10 weeks)
Title
Improvement in global functioning responses as assessed on the CGI-I scale.
Description
Change is measured as "much improved" or very much improved" on the CGI-I scale.
Time Frame
From baseline through study completion (up to 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at screening; the duration of the subjects illness must be ≥ 1year An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response too current standard of car base on the YBOCS score. Determined by the investigator to be medically stable at baseline/ randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trail as designed. Key Exclusion Criteria: Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results. Previous treatment in a study with troriluzole
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Medical Officer
Phone
203-404-0410
Email
clinicaltrials@biohavenpharma.com
Facility Information:
Facility Name
Alea Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Boschen
Phone
602-562-7000
Email
amckinney@alearesearchphoenix.com
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sun Valley Research Center, Inc.
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Individual Site Status
Withdrawn
Facility Name
Kaizen Brain Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Escamirosa
Phone
858-294-0160
Ext
114
Email
Melissa@Kaizenbraincenter.com
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Loftis
Phone
661-388-2239
Email
nloftis@omclinicaltrials.com
Facility Name
ASCLEPES ResearchCEnters, P.C.
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Withdrawn
Facility Name
CalNeuro Research Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Bystritsky
Phone
310-208-7144
Email
abystritsky@abcanxiety.com
Facility Name
North County Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
Country
United States
Individual Site Status
Withdrawn
Facility Name
CI Trials
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Individual Site Status
Withdrawn
Facility Name
Lumos Clinical Research Center, LLC
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vidwath Kashyap, LLM
Phone
408-402-5424
Email
vkashyap@lumosclinical.com
Facility Name
Velocity Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minie Mercado, LVN
Phone
714-599-8711
Email
minie.mercado@nritrials.com
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Rickers
Phone
818-990-2671
Email
stacey@cnrmg.com
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey Rosas
Phone
909-920-3000
Email
crosas@pcrmg.com
Facility Name
Mountain View Clinical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Bryant
Phone
720-941-9363
Ext
704
Email
jessica@mtnresearch.com
Facility Name
Institute of Living / Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicki Francis
Phone
860-886-1508
Ext
23
Email
vfrancis@cpccare.com
Facility Name
Topaz Clinical Research
City
Apopka
State/Province
Florida
ZIP/Postal Code
32703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Francisco, RN
Phone
407-703-4342
Email
kfrancisco@topazclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Rebecca Simpson
Phone
407-703-4342
Email
rsimpson@topazclinicalresearch.com
Facility Name
CNS Research of Coral Springs
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desiree Hinson
Phone
954-796-8222
Email
desiree@cnsresearchgroup.com
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Desiree Hinson
Phone
239-561-0009
Email
desiree@gulfcoastclinicalresearch.com
Facility Name
University of Florida Department of Psychiatry
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Individual Site Status
Withdrawn
Facility Name
Qway Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Angel
Phone
904-281-5757
Email
sangel@cnshealthcare.com
Facility Name
Clintex Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Withdrawn
Facility Name
Med-Care Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Urra
Phone
305-221-0660
Email
durra@medcareresearch.com
Facility Name
Ezy Medical Research, Co.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Withdrawn
Facility Name
Miami Dade Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Withdrawn
Facility Name
Advanced Research for Health Improvement
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Withdrawn
Facility Name
Bravo Health Care Center
City
North Bay Village
State/Province
Florida
ZIP/Postal Code
33141
Country
United States
Individual Site Status
Withdrawn
Facility Name
Harmony Clinical Research
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Pages
Phone
305-957-7200
Email
fepages@hcresearchfl.com
Facility Name
dTMS Center LLC
City
Palm Beach
State/Province
Florida
ZIP/Postal Code
33480
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elyssa Sisko
Phone
561-333-8891
Email
elyssasisko@gmail.com
Facility Name
DMI Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Hann
Phone
727-531-2848
Email
khann@dmiresearch.com
Facility Name
Olympian Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Withdrawn
Facility Name
CenExel iResearch
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abel Beck
Phone
404-537-1281
Email
abel.beck@iresearchatlanta.com
Facility Name
Renew Health Clinical Research, LLC
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Individual Site Status
Suspended
Facility Name
University of Chicago Department of Psychiatry & Behavioral Neuroscience
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madison Collins
Phone
773-702-9066
Email
mcollins4@bsd.uchicago.edu
Facility Name
AMR-Baber Research, Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Freeda Baber
Phone
630-272-4844
Email
freeda@baberresearchgroup.com
Facility Name
Collective Medical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Thomas
Phone
913-381-7180
Email
bthomas@cmr-kc.com
Facility Name
Riverstar Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Withdrawn
Facility Name
Continental Clinical Solutions, LLC
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Nelson
Phone
410-616-9566
Email
jnelson@continentalclinical.com
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Monghan
Phone
617-477-4868
Email
joanne@bostontrials.com
Facility Name
Adams Clinical
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Withdrawn
Facility Name
Psychiatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marybeth Haug, MS
Phone
636-244-3593
Email
MHAUG@PCRC-STL.COM
First Name & Middle Initial & Last Name & Degree
Jennifer Helle
Phone
636-244-3593
Email
jhelle@pcrc-stl.com
Facility Name
Boeson Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Withdrawn
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08028
Country
United States
Individual Site Status
Withdrawn
Facility Name
SPRI Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gennadiy Fink
Phone
718-616-2249
Email
gfink@spristudy.com
Facility Name
Manhattan Behavioral Medicine, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Joseph
Phone
646-678-4073
Email
joseph@nymbm.com
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Individual Site Status
Withdrawn
Facility Name
ARSMNC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Withdrawn
Facility Name
Richard H. Weisler, MD PA & Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Cofield
Phone
919-872-5900
Email
scofield@weislermd.com
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Withdrawn
Facility Name
American Clinical Research Institute (ACRI)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashesh Agrawal
Phone
937-479-9485
Email
Ashesh@acriresearch.com
Facility Name
Neurology Diagnostics, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Withdrawn
Facility Name
American Research Institute (ACRI)
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashesh Agrawal
Phone
937-479-9485
Email
ASHESH@ACRIRESEARCH.COM
Facility Name
North Star Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Habermehl
Phone
732-800-4415
Email
thabermehl@northstarresearch.org
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francine Sachafer
Phone
610-820-0342
Email
smartinez@lehighcenter.com
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saima Din
Phone
610-891-9024
Ext
1102
Email
sdin@suburbanresearch.com
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Individual Site Status
Withdrawn
Facility Name
Donald J. Garcia Jr., MD PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald J Garcia, MD, PA
Phone
512-521-0595
Email
dgarciamd@austinctp.com
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Mehkri, MD
Phone
832-606-2053
Email
inquestclinical@gmail.com
Facility Name
FutureSearch Trials of Dallas, LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Ashmore
Phone
214-369-2600
Email
erina@fstrials.com
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Green
Phone
972-283-6286
Email
bgreen@incr.us
Facility Name
NovoTrial Research Group
City
Frisco
State/Province
Texas
ZIP/Postal Code
75033
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santiago Rios
Phone
713-484-6947
Email
srios@ctntexas.com
Facility Name
AIM Trials
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Prashar
Phone
972-267-1988
Email
Sonia.prashar@aimtrials.com
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Woodstock Research Center
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Balenger
Phone
802-457-4904
Email
bbalenger@woodstockresearch.org
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aunshu Goyal
Phone
403-210-6903
Email
aunshu.goyal@ahs.ca
Facility Name
Chatham-Kent Clinical Trials Research Centre
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 1C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Handsor
Phone
519-397-3791
Email
jhandsor@ckctrc.com
Facility Name
McMaster University, Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Patterson
Phone
905-921-7644
Email
bpatter@mcmaster.ca
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Deng
Phone
613-549-6666
Email
yan.deng@queensu.ca
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iaroslava Ramos
Phone
416-480-6100
Ext
3865
Email
iaroslava.ramos@sunnybrook.ca
Facility Name
START Clinic for Mood and Anxiety Disorders
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Fotinos
Phone
416-598-9344
Email
kfotinos@startclinic.ca
Facility Name
University of Toronto / Centre for Addiction and Mental Health (CAMH)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arun Ravindran
Phone
416-535-8501
Ext
30484
Email
mood.research@camh.ca
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
State/Province
Changping District
ZIP/Postal Code
100085
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunlong Tan
Phone
139 1076 4475
Email
ytan21@126.com
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Haidian District
ZIP/Postal Code
100083
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianmei Si
Phone
139 1098 7793
Email
si.tian-mei@163.com
Facility Name
Hangzhou Seventh People's Hospital
City
Hangzhou
State/Province
Hangzhou City
ZIP/Postal Code
310063
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxin Tang
Phone
152 6855 6851
Email
twxzy8@sina.com
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Hexi District
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinggang Chen
Phone
130 1133 1322
Email
adyysk2010@163.com
Facility Name
The Second Xiangya Hospital of Central South University
City
Xiangya
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Wang
Phone
139 7311 7721
Email
Xiaop6@126.com
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiping Xie
Phone
138 5158 8810
Email
xieshiping@medmail.com.cn
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Minhang District
ZIP/Postal Code
201108
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiu Jin
Phone
158 0069 3940
Email
qiuj@union-laboratory.com
Facility Name
Wuhan Mental Health Center
City
Wuhan
State/Province
Qiaokou District
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Li
Phone
139 7116 0236
Email
psylee@163.com
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Tianhe District
ZIP/Postal Code
510660
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbin Jia
Phone
133 9248 9168
Email
Yanbinjia2006@163.com
Facility Name
Mental Health Center, West China Hospital, Sichuan University
City
Chengdu
State/Province
Wuhou District
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weihong Kuang
Phone
189 8060 1714
Email
kwhhlj@163.com
Facility Name
First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Yuhua District
ZIP/Postal Code
050001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyi Wang
Phone
186 3388 9920
Email
ydyyxuangxueyi@163.com
Facility Name
Institute of Neuroscience, University of Firenze
City
Florence
ZIP/Postal Code
50121
Country
Italy
Individual Site Status
Withdrawn
Facility Name
ASST FBF SACCO - Ospedale Universitario Luigi Sacco
City
Milan
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernardo Dell'Osso
Email
dellosso.bernardo@asst-fbf-sacco.it
Facility Name
University School of Medicine of Napoli Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea de Bartolomeis
Email
adebarto@unina.it
Facility Name
University of Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donatella Marazziti
Phone
05 72490433
Email
dmarazzi@med.unipi.it
Facility Name
University of Turin - university hospital san luigi gonzaga
City
Turin
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Maina
Email
giuseppe.maina@unito.it
Facility Name
Amsterdam UMC, locatie AMC
City
Amsterdam
ZIP/Postal Code
1100
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damiaan Denys, MD
Email
d.denys@amsterdamumc.nl
Facility Name
Leiden University Medical Center (LUMC)
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krista Koekenbier
Email
p.j.herbschleb@lumc.nl
Facility Name
Barbara Diaz Hernandez MD Research, Inc.
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Manchon
Email
jmenchon@bellvitgehospital.cat
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Ibanez
Email
aibanez.hrc@gmail.com
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanca Reneses
Email
blanca@reneses.es
Facility Name
Centro de Salud Mental La Corredoria
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leticia Garcia
Email
ensayos.saludmental@gmail.com
Facility Name
Centro de Salud San Juan
City
Salamanca
ZIP/Postal Code
37005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bárbara Buch
Email
bbuch@saludcastillayleon.es
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Rivera
Email
Tania.rivera@iisgaliciasur.es
Facility Name
MAC Clinical Research
City
Stockton-on-Tees
State/Province
County Durham
ZIP/Postal Code
TS17 6EW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Vigilante
Phone
44 16 4285 3540
Email
francescavigilante@macplc.com
Facility Name
Stemax Consult - Healthcare Services Ltd
City
Stony Stratford
State/Province
Northamptonshire
ZIP/Postal Code
MK19 6FG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olu bunmi Ljeh
Phone
019 0803 2992
Email
admin@stemaxconsult.com
Facility Name
MAC Clinical Research - South Staffordshire
City
Cannock
State/Province
South Staffordshire
ZIP/Postal Code
WS11 0BN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Allen, MD
Phone
0044 1543 501212
Email
aliceallen@macplc.com
Facility Name
MAC Clinical Research-Lancashire
City
Blackpool
ZIP/Postal Code
FY2 0JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellice Partington
Email
ellicepartington@macplc.com
Facility Name
Surrey and Borders Partnership NHS Foundation Trust
City
Chertsey
ZIP/Postal Code
KT16 0AE
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
MAC Clinical Research
City
Leeds
ZIP/Postal Code
LS10 1DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Williams
Phone
0113 272 8910
Email
ryanwilliams@macplc.com
Facility Name
MAC Clinical Research -- Merseyside
City
Liverpool
ZIP/Postal Code
L34 1BH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Jeffery
Phone
004 (0) 1514824700
Email
Ljeffery@macplc.com
Facility Name
South West London and St George's Mental Health NHS Trust Springfield University Hospital
City
London
ZIP/Postal Code
SW17 7DJ
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Greater Manchester Mental Health NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M25 3BL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leanne Howieson
Email
ocdtrial@gmmh.nhs.uk
Facility Name
Bioluminux Ltd
City
Milton Keynes
ZIP/Postal Code
MK15 0DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence ORSOLYA
Phone
+44 7884157048
Email
orsolya.lawrence@bioluminux.com
Facility Name
Kingshill Research Centre
City
Swindon
ZIP/Postal Code
SN3 6BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabarigirivasan Muthukrishnan
Phone
044 1793 327954
Email
s.muthukrishnan1@nhs.net
Facility Name
MAC Clinical Research-- South Yorkshire
City
Tankersley
ZIP/Postal Code
S75 3DL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Caddick
Email
chloecaddick@macplc.com

12. IPD Sharing Statement

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Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

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