Obsessive Compulsive DisorderPhase 4NCT02194075
Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder
A Phase 4 study testing Fluvoxamine+Methylphenidate hydrochloride and Fluvoxamine+sugar pill in people with Obsessive Compulsive Disorder, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Fluvoxamine+Methylphenidate hydrochloride and Fluvoxamine+sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 4
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent
- Met DSM-V criteria
- Y-BOCS ≥ 16
- Course of illness ≥ 1year
- Age range between 18~40 years old
- Junior high school education level above
Who cannot join
- Any other psychiatric axis-I or axis-II disorders
- History of epileptic seizures or any other neurological disorder
- Any other clinically relevant abnormalities in their medical history or laboratory examinations; alcohol or drug abuser
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong General Hospital, Guangdong academy of medical science
Guangzhou, Guangdong, 510180
About this study
Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in OCD.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Fluvoxamine+Methylphenidate hydrochloride, Fluvoxamine+sugar pill
- 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.
Fluvoxamine+Methylphenidate hydrochlorideDrug
Fluvoxamine+sugar pillDrug
| Study group | Role | What they receive |
|---|---|---|
| Fluvoxamine+Methylphenidate Hydrochloride | Active comparator | Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks.
Methylphenidate Hydrochloride: tablet, 18mg-36mg/d, were treated with a course of 8 weeks. Receives: Drug: Fluvoxamine+Methylphenidate hydrochloride |
| Fluvoxamine+sugar pill | Placebo comparator | Fluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks.
sugar pill: tablet, 1-2 tablets/d, were treated with a course of 8 weeks. Receives: Drug: Fluvoxamine+sugar pill |
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: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2015
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.
- More trials run by Guangdong Provincial People's 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sunnyrong, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194075
- Sponsor's protocol ID
- B2013006
- Status last verified
- Dec 2013
- First submitted
- 11 Jul 2014
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidate Hydrochloride Controlled-Release Tablets Augmentation Strategy for Patients With Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02194075
- Acronym / sponsor ID
- B2013006
- Conditions
- Obsessive Compulsive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Jul 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.
Explore the efficacy of methylphenidate hydrochloride controlled-release tablets add-on pharmacotherapy on clinical symptomatology and cognitive functioning in a sample of patients with obsessive-compulsive disorder (OCD) receiving fluvoxamine maleate. To test the hypothesis that methylphenidate hydrochloride controlled-release tablets augmentation of fluvoxamine treatment is well tolerated and may be proposed as an effective therapeutic strategy to improve outcome in OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluvoxamine+Methylphenidate Hydrochloride | Active comparator | Drug: Fluvoxamine+Methylphenidate hydrochlorideFluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks. Methylphenidate Hydrochloride: tablet, 18mg-36mg/d, were treated with a course of 8 weeks. |
| Fluvoxamine+sugar pill | Placebo comparator | Drug: Fluvoxamine+sugar pillFluvoxamine: tablet, 100mg-300mg/d, were treated with a course of 8 weeks. sugar pill: tablet, 1-2 tablets/d, were treated with a course of 8 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Informed consent
- Met DSM-V criteria
- Y-BOCS ≥ 16
- Course of illness ≥ 1year
- Age range between 18~40 years old
Key exclusion criteria (3 listed)
- Any other psychiatric axis-I or axis-II disorders
- History of epileptic seizures or any other neurological disorder
- Any other clinically relevant abnormalities in their medical history or laboratory examinations; alcohol or drug abuser
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 |
|---|---|---|
| Fluvoxamine+Methylphenidate hydrochloride | Drug | Fluvoxamine+Methylphenidate Hydrochloride |
| Fluvoxamine+sugar pill | Drug | Fluvoxamine+sugar pill |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 8 weeks
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 23 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fluvoxamine+Methylphenidate hydrochloride and Fluvoxamine+sugar pill in people with Obsessive Compulsive Disorder, run by Guangdong Provincial People's Hospital at 1 site in China.
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 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 23 Oct 2015. 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 China. 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 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?
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: 8 weeks). 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 23 Oct 2015.