Obsessive Compulsive DisorderNCT02103621
Assisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)
A study testing Unified Protocol (UP) and Taper and Monitoring (TAP-M) in people with Obsessive Compulsive Disorder, run by Butler Hospital at 1 site in United States.
Trial summary
This study will address questions of fundamental clinical significance including: (1) whether OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation, (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following discontinuation compared to Taper and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Unified Protocol (UP) and Taper and Monitoring (TAP-M)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- Presence of mild to moderate OCD symptoms
- Patient's treating clinician agrees that SRI discontinuation is clinically appropriate
- Adequate trial of SRI (≥10 weeks) in the current treatment episode
- Maintenance on SRI dose that has not increased due to significant clinical worsening in the two years prior to enrollment
- English speaking
Who cannot join
- Clinically significant suicidality or a suicide attempt within the past year
- Presence of any clinical features warranting a higher level of care (partial or inpatient hospitalization)
- Current or recent (past 6 months) alcohol or drug dependence or abuse
- Current or past psychotic disorder or bipolar disorder
- Moderate to severe depression, as indicated by a Hamilton Rating Scale for Depression (HRSD) (17-item) ≥ 14 or recent major depressive episode (past 6 months)
- History of severe OCD (YBOCS ≥ 28)
Show all 12Show fewer
- Prior adverse experience with SRI discontinuation
- Primary compulsive hoarding
- Cognitive impairment that would interfere with study participation
- Concomitant psychosocial treatment w/ proven efficacy in the treatment of OCD
- Previous adequate trial of exposure-based treatment (e.g., history of 12 or more sessions) in past 5 years
- Use of non-SRI psychotropic medications for OCD in the 3 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder
This study will address questions of fundamental clinical significance including: (1) whether OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation, (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following discontinuation compared to Taper and Monitoring, and (3) whether predictors of successful SRI discontinuation can be identified.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Unified Protocol (UP), Taper and Monitoring (TAP-M)
- 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.
Unified Protocol (UP)Behavioural
Taper and Monitoring (TAP-M)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Unifed Protocol (UP) for Discontinuation | Experimental | Unified Protocol (UP) for Discontinuation is delivered in 14 weekly individual sessions of 45-60 minutes followed by 3 booster sessions scheduled at two, four and eight weeks thereafter. The UP is a cognitive behavioral treatment that focuses on increasing emotional awareness and cognitive flexibility, preventing behavioral and emotional avoidance, and situational and interoceptive emotion-focused exposure. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication. Receives: Behavioral: Unified Protocol (UP) |
| Taper and Monitoring (TAP-M) | Active comparator | Taper and Monitoring (TAP-M) is delivered in biweekly individual sessions over 14 weeks, with booster sessions at two, four, and eight weeks thereafter. TAP-M consists of assessment and monitoring. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication. Receives: Behavioral: Taper and Monitoring (TAP-M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: 14 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Christina L Boisseau, Ph.D., Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103621
- Sponsor's protocol ID
- 1402-002
- Other IDs
- 1R21MH100444-01A1, 1402-002
- Status last verified
- Jun 2018
- First submitted
- 1 Apr 2014
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02103621
- Acronym / sponsor ID
- 1402-002
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
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 address questions of fundamental clinical significance including: (1) whether OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation, (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following discontinuation compared to Taper and Monitoring, and (3) whether predictors of successful SRI discontinuation can be identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unifed Protocol (UP) for Discontinuation | Experimental | Behavioral: Unified Protocol (UP)Unified Protocol (UP) for Discontinuation is delivered in 14 weekly individual sessions of 45-60 minutes followed by 3 booster sessions scheduled at two, four and eight weeks thereafter. The UP is a cognitive behavioral treatment that focuses on increasing emotional awareness and cognitive flexibility, preventing behavioral and emotional avoidance, and situational and interoceptive emotion-focused exposure. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication. |
| Taper and Monitoring (TAP-M) | Active comparator | Behavioral: Taper and Monitoring (TAP-M)Taper and Monitoring (TAP-M) is delivered in biweekly individual sessions over 14 weeks, with booster sessions at two, four, and eight weeks thereafter. TAP-M consists of assessment and monitoring. Participants will also receive 7 biweekly medication management sessions over 14 weeks with a study psychiatrist to facilitate gradual taper of SRI medication. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 or older
- Presence of mild to moderate OCD symptoms
- Patient's treating clinician agrees that SRI discontinuation is clinically appropriate
- Adequate trial of SRI (≥10 weeks) in the current treatment episode
- Maintenance on SRI dose that has not increased due to significant clinical worsening in the two years prior to enrollment
Key exclusion criteria (12 listed)
- Clinically significant suicidality or a suicide attempt within the past year
- Presence of any clinical features warranting a higher level of care (partial or inpatient hospitalization)
- Current or recent (past 6 months) alcohol or drug dependence or abuse
- Current or past psychotic disorder or bipolar disorder
- Moderate to severe depression, as indicated by a Hamilton Rating Scale for Depression (HRSD) (17-item) ≥ 14 or recent major depressive episode (past 6 months)
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 |
|---|---|---|
| Unified Protocol (UP) | Behavioural | Unifed Protocol (UP) for Discontinuation |
| Taper and Monitoring (TAP-M) | Behavioural | Taper and Monitoring (TAP-M) |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 14 weeks post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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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.
Christina L Boisseau, Ph.D. principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol (UP) and Taper and Monitoring (TAP-M) in people with Obsessive Compulsive Disorder, run by Butler 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 6 inclusion and 12 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 14 Jun 2018. 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.
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?
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: 14 weeks post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2018.