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| ID | Type | Description | Link |
|---|---|---|---|
| 5731-04-4R0 | Other Identifier | Duke legacy protocol number |
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.
OCD is a chronic and disabling disorder for which Selective Serotonin Reuptake Inhibitor(SSRI) drugs can be effective. The purpose of this study is to evaluate the effects of an SSRI, escitalopram, in OCD patients.
This study will last 16 weeks and will comprise 2 phases. Phase 1 is an open label in which all participants will receive daily escitalopram for 8 weeks. Those who have responded to treatment at the end of the 8 weeks will be randomly assigned to either continue or discontinue their treatment for an additional 8 weeks. Those who do not respond to treatment at the end of Phase 1 will discontinue the study and be offered three free visits with a study clinician or referred elsewhere for treatment, based on the their preference. Study visits are made at baseline, and at Weeks 1, 2, 4, and 8 in Phase 1 and Weeks 12 and 16 in Phase 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Escitalopram 10-20 mg/daily | Experimental | Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. |
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| Randomizationn Placebo 10-20 mg daily | Placebo Comparator | Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). |
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| Randomization Escitalopram 10-20 mg/daily | Active Comparator | Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug | Open label Treatment: Escitalopram 10 mg/day for 1 week and then 20 mg /day for 7 weeks. Double Blind Treatment: Escitalopram 20 mg/day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale | The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty. | Open Label Phase Baseline,Randomization Phase Baseline or Beginning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei M. Zhang, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | C. Joseph Wang, M.D., Ph.D.; Jonathan R. Davidson, M.D.; Kathryn M. Connor, M.D.;Weihui Li1, M.D.,Ph.D. and Wei Zhang, M.D., Ph.D. Unpublished Manuscript |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Escitalopram | Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. |
| FG001 | Randomization Placebo | Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). |
| FG002 | Randomization Escitalopram | Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open Label Escitalopram |
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| Randomization Period |
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Only the open label treatment phase is being reported per reviewer's instructions. The other arms are for the second phase of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Escitalopram | Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Yale Brown Obsessive Compulsive Scale | The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty. | Posted | Mean | Standard Deviation | units on a scale | Open Label Phase Baseline,Randomization Phase Baseline or Beginning |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Escitalopram | Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhang MD | Duke University Medical Center Dept of Psychiatry | 919 684 5645 | wei.zhang@duke.edu |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
| Placebo ( sugar pill) | Drug | Placebo Comparator in double.blind phase. |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post beginning of the study phase sample. |
| OG002 | Randomization Escitalopram | Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from beginning of the study phase sample. |
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|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Randomization Placebo | Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). | 0 | 7 | 0 | 7 |
| EG002 | Randomization Escitalopram | Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). | 0 | 5 | 0 | 5 |
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |