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Obsessive-Compulsive DisorderPhase 2NCT01674361

A Study of Bitopertin (RO4917838) in Combination With Selective Serotonin Reuptake Inhibitors (SSRIs) in Participants With Obsessive-Compulsive Disorder (OCD)

A Phase 2 study testing Bitopertin and SSRI in people with Obsessive-Compulsive Disorder, run by Hoffmann-La Roche at 34 sites in 2 countries.

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 multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with obsessive-compulsive disorder. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Bitopertin and SSRI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
34 sitesin 2 countries
Study dates
31 Dec 2012to 30 Apr 2015
Phase
Phase 2
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  • On a stable dose of SSRI for at least 8 weeks prior to screening an between screening and Day 1
  • An insufficient response to current treatment with an SSRI given at an adequate dose for at least 12 weeks prior to Day 1
  • Females who are not postmenopausal or surgically sterile and who have (or may have) male sexual partners must agree to use two adequate methods of contraception as defined by protocol from the start of screening until 90 days after the last dose of study drug

Who cannot join

  • Primary OCD symptom of hoarding
  • More than two unsatisfactory trials within the last 2 years with different serotonin reuptake inhibitors (not including the current treatment with an SSRI) given in an adequate dose for at least 12 weeks
  • Failure of more than three augmentation therapies within the last 2 years
  • Undergoing acute behavioral therapy or having acute behavioral therapy that was completed less than 4 weeks prior to Day 1
  • Any primary DSM-IV-TR Axis I disorder other than OCD
  • Current or prior history of bipolar disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, or Gilles de la Tourette syndrome if symptoms have persisted into adulthood
Show all 13Show fewer
  • Any eating disorder within the last 6 months
  • History of DSM-IV-TR-defined substance dependence and/or substance abuse in the last 6 months, with the exception of nicotine
  • Previous treatment with bitopertin or another Glycine transporter 1 inhibitor
  • Positive urine drug screening for cannabis, amphetamines (including 3,4-methylenedioxymethamphetamine [MDMA]/ecstasy), cocaine, barbiturate, and/or opiates
  • Prior or current general medical condition that may impair cognition or other neuropsychiatric functioning
  • Body mass index less than (<) 18.5 kilogram per square meter (kg/m^2) or greater than (>) 40 kg/m^2
  • Pregnant or lactating women

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States27 sites

  • FutureSearch Trials, LP

    Austin, Texas, 78731

  • Massachusetts General Hospital - East

    Boston, Massachusetts, 02114

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Uni of Chicago; Centre For Advanced Medicine

    Chicago, Illinois, 60637

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Eastside Therapeutic Resource

    Kirkland, Washington, 98033

  • Compass Research North, LLC

    Leesburg, Florida, 34748

  • Clinical Neuroscience Solutions,Inc

    Memphis, Tennessee, 38119

  • North Star Research

    Middleburg Heights, Ohio, 44130

  • Dean Foundation

    Middleton, Wisconsin, 53562

  • Ambulatory Research Center (ARC), Department of Psychiatry

    Minneapolis, Minnesota, 55454

  • Yale University School of Medicine; Neuroscience Research Training Program

    New Haven, Connecticut, 06519

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • Mount Sinai School of Medicine; Department of Psychiatry

    New York, New York, 10029

  • Medical Research Network - New York

    New York, New York, 10128

  • Keystone Clinical Studies, LLC

    Norristown, Pennsylvania, 19403

  • Excell Research

    Oceanside, California, 92056

  • Ips Research Company

    Oklahoma City, Oklahoma, 73103

  • Medical Research Group of Central Florida

    Orange City, Florida, 3273

  • Butler Hospital - Department of Psychiatry and Human Behavior

    Providence, Rhode Island, 02906

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Carman Research

    Smyrna, Georgia, 30080

  • St Louis Clinical Trials

    St Louis, Missouri, 63141

  • University of South Florida

    St. Petersburg, Florida, 33701

  • Stanford University School of Medicine

    Stanford, California, 94305

  • University of South Florida

    Tampa, Florida, 33613-4706

Other trials in United States

Canada7 sites

  • Chokka Center for Integrative Health

    Edmonton, Alberta, T6L 6W6

  • True North Clinical Research-Halifax

    Halifax, Nova Scotia, B3S 1M7

  • McMaster University - MacAnxiety Research Centre

    Hamilton, Ontario, L8S 1B7

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 2H4

  • True North Clinical Research Kentville

    Kentville, Nova Scotia, B4N 4K9

  • Sunny Johnson Medical Research Associates Inc.; Medical Research Associates

    Mississauga, Ontario, L5M 4N4

  • START Clinic for Mood & Anxiety Disorders

    Toronto, Ontario, M4W 2N4

Other trials in Canada

About this study

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Combination With Selective Serotonin Reuptake Inhibitors in Patients With Obsessive Compulsive Disorder

This multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of bitopertin in combination with SSRI in participants with obsessive-compulsive disorder. Participants will be randomized to receive either bitopertin 30 milligrams (mg) or bitopertin 10 mg or placebo orally daily in addition to their background therapy with an SSRI. Participants will be allocated to one of two strata. Participants in Stratum 1 will start study drug on Day 1. Participants in Stratum 2 will receive placebo from Day 1 (placebo lead-in) and will then start study drug at the Week 2 visit. Participants in both strata will receive the study drug in addition to their background therapy with an SSRI until Week 16.

Being tested
Bitopertin, Placebo, SSRI
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

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

  • BitopertinDrug

    Also called RO4917838

    Bitopertin once daily orally.

  • PlaceboDrug

    Placebo matched to bitopertin once daily orally.

  • SSRIDrug

    Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen.

Study groups in NCT01674361
Study groupRoleWhat they receive
Bitopertin 30 mgExperimentalParticipants in Stratum 1 will receive bitopertin 30 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 30 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI.
Receives: Drug: Bitopertin; Drug: Placebo; Drug: SSRI
Bitopertin 10 mgExperimentalParticipants in Stratum 1 will receive bitopertin 10 mg from Day 1 to Week 16 in addition to their background therapy with an SSRI. Participants in Stratum 2 will receive placebo from Day 1 and will then start bitopertin 10 mg at the Week 2 until Week 16 in addition to their background therapy with an SSRI.
Receives: Drug: Bitopertin; Drug: Placebo; Drug: SSRI
PlaceboPlacebo comparatorParticipants (both Stratum 1 and Stratum 2) will receive placebo from Day 1 to Week 16 in addition to their background therapy with an SSRI.
Receives: Drug: Placebo; Drug: SSRI

What is being measured

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

  1. Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14

Secondary outcomes (10)

  1. Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14

  2. Percentage of Participants with Response as per Pre-defined Criteria Based on the Y-BOCS and CGI

    Response will be defined as having:

    At least a 35 percent (%) reduction on the total Y-BOCS score from baseline. A much or very much improved on the Clinical Global Impression of Change (CGI-C) rating from baseline.

    A combination of at least 35% reduction on the total Y-BOCS score from baseline and much or very much improved on the CGI-C from baseline.

    Achieved remission, as shown by a total Y-BOCS score less than or equal to (≤)10.

    Measured: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14

  3. Change From Baseline in Global Social Functioning Using Sheehan Disability Scale (SDS) Total Score After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14

  4. Change From Baseline in Global Social Functioning Using SDS Domain Scores After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14

  5. Change From Baseline in Obsessive Compulsive Inventory-Revised (OCI-R) Score After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14

  6. Change From Baseline in Columbia Suicide Severity Rating Scale After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14

  7. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14

  8. Change From Baseline in SF-36 - Physical Component Summary After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14

  9. Change From Baseline in SF-36 - Domain Scores After 12 Weeks of Treatment

    Measured: Stratum 1: Baseline (Day 1) up to Week 12; Stratum 2: Baseline (Week 2) up to Week 14

  10. Area Under The Concentration-Time Curve of Bitopertin

    Measured: Pre-dose (0 hour) on Day 56 (Week 8), Day 84 (Week 12), Day 98 (Week 14), Day 112 (Week 16); 3 and 6 hours post-dose on Day 112 (Week 16)

Timeline

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

  1. First posted28 Aug 2012 (estimated)
  2. Study start31 Dec 2012
  3. Primary completion30 Apr 2015
  4. Study completion30 Apr 2015

Resources

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
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01674361
Sponsor's protocol ID
WN28137
Status last verified
Jul 2017
First submitted
15 Aug 2012
Last updated
2 Aug 2017
Results posted
No

Publications

  • Bandeira ID, Lins-Silva DH, Cavenaghi VB, Dorea-Bandeira I, Faria-Guimaraes D, Barouh JL, Jesus-Nunes AP, Beanes G, Souza LS, Leal GC, Sanacora G, Miguel EC, Sampaio AS, Quarantini LC. Ketamine in the Treatment of Obsessive-Compulsive Disorder: A Systematic Review. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):135-145. doi: 10.1097/HRP.0000000000000330.

    PubMed 35267254

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bitopertin and SSRI in people with Obsessive-Compulsive Disorder, run by Hoffmann-La Roche at 34 sites in 2 countries.

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 4 inclusion and 13 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 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change From Baseline in Total Score on Yale-Brown Obsessive Compulsive Scale (Y-BOCS) After 12 Weeks of Treatment (time frame: Stratum 1: Baseline (Day 1), Week 12; Stratum 2: Baseline (Week 2), Week 14). 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 NCT01674361, 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 2 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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