Obsessive Compulsive DisorderPhase 4FIJ-MC-1003NCT00464698
Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)
A Phase 4 study testing Duloxetine in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of Duloxetine in the treatment of 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?
- Duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2013
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of OCD by DSM-IV
- Age 18-65
- Y-BOCS greater than 20
- Written informed consent
- Females of childbearing potential must have a negative serum or urinary beta-HCG test.
Who cannot join
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
- Patients who, in the investigator's judgment, pose a serious suicidal or homicidal risk.
- Serious or unstable medical illness including cardiovascular (including hypertension), hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
- History of seizure disorder
- Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder
- If there is a history of substance abuse, patients in remission at least 6 months.
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- Currently being treated with behavioral therapy, specifically exposure and response prevention, for OCD.
- Other medications for medical disorders that may interfere with duloxetine
- Current major depression or prescribed an antidepressant for major depression within the past 12 months. We will assess depressive symptoms with the BDI throughout the course of the study in order to assess subsyndromal depressive symptoms and to assess for the emergence of depressive symptoms.
- Taken other psychotropic medication within 2 weeks of beginning the study (4 weeks for fluoxetine).
- More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another SSRI in the past.
- Known hypersensitivity to duloxetine or any of the inactive ingredients.
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI drug during the study or within 5 days of discontinuation of study drug.
- Patients with uncontrolled narrow-angle glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Duloxetine for the Treatment of Obsessive Compulsive Disorder
The purpose of this study is to assess the efficacy of Duloxetine in the treatment of obsessive compulsive disorder.
Read the detailed description
Obsessive compulsive disorder affects approximately 3% of the population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhibitors (SNRIs), and behavioral therapy. Duloxetine is a new SNRI. This study aims to assess the efficacy of duloxetine for the treatment of OCD.
Before subjects give written informed consent, they are made aware of alternatives to participation in this study, which can include independently seeking pharmacotherapy or cognitive behavioral treatment for OCD. Patients will then begin open-label treatment with duloxetine at 30 mg/day and will be seen again in one week (Visit 2). At Visit 2, patients will be assessed and, if they are not experiencing any significant side effects, the dose will be increased to 60 mg/day. Patients who are experiencing significant side effects at 30 mg/day will be discontinued from the study and offered standard treatment in our clinic. Patients taking 60 mg/day will then return for assessment in four weeks (Visit 3). At this time, if they are not experiencing any significant side effects, the dose will then be increased to 120 mg/day. Patients who are unable to tolerate 120 mg/day will have their dose decreased back down to 60 mg/day and will continue the trial. End of study final statistical analyses will be conducted both including and excluding these patients. Remaining assessments will be every 4 weeks (Visits 4, 5, 6). Thus, in total this is a 17-week study with 12 weeks at the high dose believed to be necessary for response.
At each visit following the initial visit, patients will be assessed using the Y-BOCS, BDI, BAI, and CGI. The Q-LES-Q will only be administered at the initial and last visit.
The study procedure is similar to standard medical treatment for OCD at MGH. Like standard care, participants start on the lowest dose of the medication and then increase that dose to the maximally tolerated level. Barring any significant side effects, the patient remains on that dose for 4-8 weeks to provide the medication with an adequate trial period. At the end of that period, efficacy would be assessed and other alternatives would be discussed.
One difference between the study and standard care is that the study will provide more assessment through verbal and written scales. This additional assessment could greatly benefit the patient as they decide between other treatment options. Another difference is that participants cannot be involved in current behavior therapy throughout the study. Many patients choose to pursue medical treatment without behavior therapy in standard care; however, in standard care, they have the option of pursuing both concurrently or pursuing just behavior therapy. If a patient wishes to pursue just behavior therapy or receive medication and therapy concurrently, then other forms of treatment at MGH might be more appropriate. If they only want medical treatment, the study is similar to standard care at a lower cost.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Duloxetine
- Keywords
- OCD, Obsessive Compulsive Disorder, Obsessions, Compulsions, Duloxetine, Cymbalta
- Medical subject headings
- Obsessive-Compulsive Disorder, Obsessive Behavior, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Participants received increasing amounts of Duloxetine for 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| All Study Participants | Experimental | Duloxetine 30mg: Dose level 1 (Week 1) Duloxetine 60mg: Dose level 2 (Wks 2-4) Duloxetine 120mg: Dose level 3 (Wks 3-7) Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-BOCS Scores at 1st and Last Visit
OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.
Measured: Week 0 to 17
Secondary outcomes (4)
BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17).
Depression severity, such that higher scores on the BDI are reflective of more severe depression.
BDI minimum score: 0 MDI maximum score: 63
Measured: Week 0 to 17
BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17)
Anxiety severity, such that a higher score on the BAI reflects more severe anxiety.
Minimum value: 0 Maximum value: 63
Measured: Week 0 to 17
QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17)
Quality of life, such that lower score reflects poorer quality of life
Minimum score: 16 Maximum score: 80
Measured: Week 0 to 17
Clinical Global Impressions Scale at Week 3 and Week 17
Global severity of illness, such that a higher score reflects worse global severity
Minimum score: 2 Maximum score: 14
Measured: Week 3 to 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startDec 2005
- Primary completionDec 2013
- Study completionDec 2013
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 Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Darin Dougherty, Massachusetts General Hospital
- Investigators
- Darin D Dougherty, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464698
- Sponsor's protocol ID
- 2005-P-002159
- Other IDs
- FIJ-MC-1003
- Acronym
- FIJ-MC-1003
- Status last verified
- Mar 2019
- First submitted
- 23 Apr 2007
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dougherty DD, Corse AK, Chou T, Duffy A, Arulpragasam AR, Deckersbach T, Jenike MA, Keuthen NJ. Open-label study of duloxetine for the treatment of obsessive-compulsive disorder. Int J Neuropsychopharmacol. 2015 Jan 30;18(2):pyu062. doi: 10.1093/ijnp/pyu062. Print 2015.
PubMed 25637377
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine for the Treatment of Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00464698
- Acronym / sponsor ID
- FIJ-MC-1003 / 2005-P-002159
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- OCD, Obsessive Compulsive Disorder, Obsessions, Compulsions, Duloxetine, Cymbalta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Dec 2005
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Apr 2007 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of Duloxetine in the treatment of obsessive compulsive disorder.
Detailed description
Obsessive compulsive disorder affects approximately 3% of the population. Treatment options include the selective serotonin reuptake inhibitors (SSRIs), dual serotonin and norepinephrine reuptake inhibitors (SNRIs), and behavioral therapy. Duloxetine is a new SNRI. This study aims to assess the efficacy of duloxetine for the treatment of OCD.
Before subjects give written informed consent, they are made aware of alternatives to participation in this study, which can include independently seeking pharmacotherapy or cognitive behavioral treatment for OCD. Patients will then begin open-label treatment with duloxetine at 30 mg/day and will be seen again in one week (Visit 2). At Visit 2, patients will be assessed and, if they are not experiencing any significant side effects, the dose will be increased to 60 mg/day. Patients who are experiencing significant side effects at 30 mg/day will be discontinued from the study and offered standard treatment in our clinic. Patients taking 60 mg/day will then return for assessment in four weeks (Visit 3). At this time, if they are not experiencing any significant side effects, the dose will then be increased to 120 mg/day. Patients who are unable to tolerate 120 mg/day will have their dose decreased back down to 60 mg/day and will continue the trial. End of study final statistical analyses will be conducted both including and excluding these patients. Remaining assessments will be every 4 weeks (Visits 4, 5, 6). Thus, in total this is a 17-week study with 12 weeks at the high dose believed to be necessary for response.
At each visit following the initial visit, patients will be assessed using the Y-BOCS, BDI, BAI, and CGI. The Q-LES-Q will only be administered at the initial and last visit.
The study procedure is similar to standard medical treatment for OCD at MGH. Like standard care, participants start on the lowest dose of the medication and then increase that dose to the maximally tolerated level. Barring any significant side effects, the patient remains on that dose for 4-8 weeks to provide the medication with an adequate trial period. At the end of that period, efficacy would be assessed and other alternatives would be discussed.
One difference between the study and standard care is that the study will provide more assessment through verbal and written scales. This additional assessment could greatly benefit the patient as they decide between other treatment options. Another difference is that participants cannot be involved in current behavior therapy throughout the study. Many patients choose to pursue medical treatment without behavior therapy in standard care; however, in standard care, they have the option of pursuing both concurrently or pursuing just behavior therapy. If a patient wishes to pursue just behavior therapy or receive medication and therapy concurrently, then other forms of treatment at MGH might be more appropriate. If they only want medical treatment, the study is similar to standard care at a lower cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Study Participants | Experimental | Drug: DuloxetineDuloxetine 30mg: Dose level 1 (Week 1) Duloxetine 60mg: Dose level 2 (Wks 2-4) Duloxetine 120mg: Dose level 3 (Wks 3-7) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of OCD by DSM-IV
- Age 18-65
- Y-BOCS greater than 20
- Written informed consent
- Females of childbearing potential must have a negative serum or urinary beta-HCG test.
Key exclusion criteria (14 listed)
- Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception.
- Patients who, in the investigator's judgment, pose a serious suicidal or homicidal risk.
- Serious or unstable medical illness including cardiovascular (including hypertension), hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease. Patients on anticoagulant therapy.
- History of seizure disorder
- Comorbid bipolar disorder, psychosis, organic mental disorder, or developmental disorder
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 |
|---|---|---|
| DuloxetineAlso: CymbaltaParticipants received increasing amounts of Duloxetine for 7 weeks. | Drug | All Study Participants |
Primary outcome
Y-BOCS Scores at 1st and Last Visit
Time frame: Week 0 to 17
OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.
4 secondary outcomes
BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17).
Time frame: Week 0 to 17
BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17)
Time frame: Week 0 to 17
QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17)
Time frame: Week 0 to 17
Clinical Global Impressions Scale at Week 3 and Week 17
Time frame: Week 3 to 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25637377Dougherty DD, Corse AK, Chou T, Duffy A, Arulpragasam AR, Deckersbach T, Jenike MA, Keuthen NJ. Open-label study of duloxetine for the treatment of obsessive-compulsive disorder. Int J Neuropsychopharmacol. 2015 Jan 30;18(2):pyu062. doi: 10.1093/ijnp/pyu062. Print 2015.
- PubMedLink provided by the sponsor.
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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.
Darin D Dougherty, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital at 1 site 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 5 inclusion and 14 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Mar 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?
Y-BOCS Scores at 1st and Last Visit (time frame: Week 0 to 17). 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 NCT00464698, 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 Mar 2019.