Obsessive Compulsive DisorderPhase 4NCT00723060
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder
A Phase 4 study testing escitalopram in people with Obsessive Compulsive Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD). 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?
- escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Jan 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman, aged 18 to 65 years, outpatient
- Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months
- Severity: Y-BOCS score of >= 20 at screening and baseline
- No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening
- Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration.
Who cannot join
- primary active DSM-IV axis I diagnosis other than OCD
- History of substance, including alcohol, dependence and psychotic symptoms
- Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of >17 at screening or baseline
- Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity
- History of no response to escitalopram or citalopram treatment
- History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening
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- Women who are pregnant, planning to become pregnant, or breast-feeding
- Ongoing cognitive behavior therapy (CBT) of OCD
- Hoarding or collecting type
- Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder (Randomized, Double-blind, Multi-center Study)
OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD).
OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind, Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS: Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S \& -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events / Serious Adverse Events, UKU
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- escitalopram
- 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.
escitalopramDrug
escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | escitalopram high dose group Receives: Drug: escitalopram |
| 2 | Active comparator | escitalopram conventional group Receives: Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of Y-BOCS score average from baseline to 16-week
Measured: baseline and16-week
Secondary outcomes (1)
1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A
Measured: every 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2011
- Study completionJan 2011
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 Seoul National University 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jun Soo Kwon, M.D., Ph.D., Principal investigator, Seoul National University Hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723060
- Sponsor's protocol ID
- 11769A
- Status last verified
- Aug 2011
- First submitted
- 24 Jul 2008
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder (Randomized, Double-blind, Multi-center Study)
- ClinicalTrials.gov ID
- NCT00723060
- Acronym / sponsor ID
- 11769A
- Conditions
- Obsessive Compulsive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Jul 2008 (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.
OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD).
OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind, Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS: Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S \& -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events / Serious Adverse Events, UKU
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: escitalopramescitalopram high dose group |
| 2 | Active comparator | Drug: escitalopramescitalopram conventional group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman, aged 18 to 65 years, outpatient
- Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months
- Severity: Y-BOCS score of >= 20 at screening and baseline
- No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening
- Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration.
Key exclusion criteria (10 listed)
- primary active DSM-IV axis I diagnosis other than OCD
- History of substance, including alcohol, dependence and psychotic symptoms
- Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of >17 at screening or baseline
- Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity
- History of no response to escitalopram or citalopram treatment
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 |
|---|---|---|
| escitalopramescitalopram high dose group (40mg) escitalopram conventional dose group (20mg) | Drug | 1, 2 |
Primary outcome
The difference of Y-BOCS score average from baseline to 16-week
Time frame: baseline and16-week
1 secondary outcome
1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A
Time frame: every 2 week
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 8 Aug 2011.
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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.
Jun Soo Kwon, M.D., Ph.D. principal investigator
Seoul National University Hospital, Seoul, Korea
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 escitalopram in people with Obsessive Compulsive Disorder, run by Seoul National University Hospital at 1 site in South Korea.
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 10 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 8 Aug 2011. 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 South Korea. 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?
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?
The difference of Y-BOCS score average from baseline to 16-week (time frame: baseline and16-week). 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 8 Aug 2011.