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The purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).
The purpose of this study is to determine whether memantine (Namenda), in doses up to 20 mg/day, will be effective in treating the OCD of adult patients who have not responded to their OCD medication. Memantine is not FDA approved for OCD, but is approved for the treatment of Alzheimer's Disease. Memantine appears to work by regulating the activity of glutamate, one of the brain's specialized messenger chemicals, which may play a role in OCD. All patients in the study will receive memantine; no one will receive placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantine open label | Experimental | All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks) | The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks) | The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a scale of 0 (no symptoms) to 6 (extreme symptoms) and items are summed. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John J Barry, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19142108 | Result | Aboujaoude E, Barry JJ, Gamel N. Memantine augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. J Clin Psychopharmacol. 2009 Feb;29(1):51-5. doi: 10.1097/JCP.0b013e318192e9a4. |
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From February 2006 to February 2008, participants recruited from the Stanford School of Medicine Department of Psychiatry and Behavioral Sciences OCD clinic and through online adds. Subjects had to have had failed to respond to at least 12 weeks of treatment at an adequate and stable dose of an serotonin reuptake inhibitor (SRI) (YBOCS of GE 18)
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine Open Label | All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally. Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Memantine Open Label | All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally. Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks) | The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
12 weeks of study medication dosing
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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 | Memantine Open Label | All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally. Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment | Mild to moderate, transient in duration |
This study is limited by its open-label design, small size, and the presence of comorbidities and concurrent psychotropic medications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr John Barry, Professor | Stanford University School of Medicine, Dept of Psychiatry | (650) 725-5588 | jbarry@stanford.edu |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Baseline and 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Yale-Brown Obsessive Compulsive Scale | The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity | Mean | Standard Deviation | units on a scale |
|
| Psychiatric comorbid condition | Number | participants |
|
| OG001 | Non-Responders: Memantine Open Label | Participants who did not respond to memantine as adjunctive therapy |
|
|
| Secondary | Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks) | The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a scale of 0 (no symptoms) to 6 (extreme symptoms) and items are summed. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| 0 |
| 14 |
| 7 |
| 14 |
|
| Headache | Nervous system disorders | MedDRA (7.0) | Systematic Assessment | Mild to moderate, transient in duration |
|
| Somnolence | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment | Mild to moderate, transient in duration |
|
| Night sweats | General disorders | MedDRA (7.0) | Systematic Assessment | Mild to moderate, transient in duration |
|
| Light-headedness | Investigations | MedDRA (7.0) | Systematic Assessment | Mild to moderate, transient in duration |
|
| Fatigue | Nervous system disorders | MedDRA (7.0) | Systematic Assessment | Mild to moderate, transient in duration |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |