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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 12, 2006 | ||||||||
| Last Updated Date | December 16, 2008 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hamilton Anxiety Scale [ Time Frame: 10 wk ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00411398 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A 10 Week Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Memantine(Namenda) as Augmentation Therapy in Patients With Generalized Anxiety Disorder | ||||||||
| Official Title ICMJE | A 10 Week Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Memantine(Namenda) as Augmentation Therapy in Patients With Generalized Anxiety Disorder (GAD) or Social Anxiety Disorder (SAD), Who Are Only Partial Responders to Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's) or Selective Serotonin Reuptake Inhibitors (SSRI's). | ||||||||
| Brief Summary | This study is being conducted to evaluate the safety and effectiveness of memantine Add-On treatment of patients who are currently taking an SNRI or SSRI and who remain anxious and symptomatic despite treatment. Secondary objectives of this study are: •-to evaluate if there is an improvement in disability levels following memantine dosing -to evaluate if there is an improvement in sleep quality following memantine dosing |
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| Detailed Description | Memantine is an FDA approved treatment which helps slow down the progression of Alzheimer's dementia.. It is felt that high glutamate levels associated with Alzheimer's dementia are toxic to neurons which ultimately die off causing the dementia process to continue. Memantine partially blocks the NMDA glutamate channels located on neurons in the brain. This way, if glutamate rises, its toxic activity is blunted and neurons tend to become less toxic and suffer less atrophy and death. Glutamate is felt to play a role in the development of anxiety as well. Glutamate is often in balance with another neurotransmitter, GABA. This GABA-glutamate balance (when GABA is low and Glutamate is normal to high) is also felt to play a role in the development of GAD or SAD. Low GABA and high glutamate levels (similar to the state of alcohol withdrawal) are implicated in causing anxiety symptoms. Sometimes, GABA-increasing sedative drugs, such as diazepam (Valium) are used to raise GABA activity to ward of anxiety symptoms and create a better balance between the stimulatory glutamate and inhibitory GABA. Given memantine's ability to lower glutamate levels, it may be able to also lower anxiety without the need for a sedative medication. Lowering glutamate this way, may allow a patient's own GABA concentrations to be more effective in lowering GAD or SAD symptoms. The usual treatment in initial treatment for anxiety is to use a serotonin neurotransmitter enhancing drug, such as paroxetine or escitalopram. These 'SSRI' drugs, unlike the sedatives noted above, do not have addiction potential and are safer to use. In the anxiety disorder population, only 30-70% of patients achieve full remission of anxiety symptoms when placed on SSRI monotherapy. The usual second-line choice is to treat with a serotonin-norepinephrine enhancing SNRI, such as venlafaxineXR in order to achieve remission. If resistance occurs to the SNRI, to promote full anxiety symptom relief, addition of a GABA enhancing-sedative (to raise GABA balance) to the SNRI is a reasonable polypharmacy strategy. Sedatives, like alprazolam, are addictive and considered third line agents now. The authors feel that memantine, given its ability to manipulate the GABA-glutamate balance by lowering glutamate without major side effects (weight gain, sexual problems, (ie SSRI/SNRI) nor addiction (ie sedatives) may be a reasonable add-on or augmentation strategy to better alleviate anxiety in SNRI or SSRI partial responders. This study is designed to evaluate generally or socially anxious patients who are only partially responsive to typical SNRI or SSRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SNRI medication will be asked to join the study and be placed on memantine as well. This type of add-on therapy is common in outpatient psychiatric care. This is a rater-blinded, patient open-label, non-placebo prospective pilot study, where all subjects will receive memantine for 10 weeks. This study would be the first to date in this treatment-resistant patient population, as the investigators will utilize the most comprehensive set of rating scales to date in order to best categorize patient responses in regards to anxiety with this drug. |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | General Anxiety Disorder, Social Anxiety Disorder | ||||||||
| Intervention ICMJE | Drug: Namenda/Memantine | ||||||||
| Study Arms / Comparison Groups | Experimental: Memantine tablets | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 15 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:Patients are included in the study if all of the following criteria are met:
Patients are included in the study if all of the following criteria are met:
Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met:
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| Gender | Both | ||||||||
| Ages | 18 Years to 64 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00411398 | ||||||||
| Responsible Party | thomas schwartz, SUNY Upstate | ||||||||
| Study ID Numbers ICMJE | NAM-MD-46, IRB # 5343 | ||||||||
| Study Sponsor ICMJE | State University of New York - Upstate Medical University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | State University of New York - Upstate Medical University | ||||||||
| Verification Date | December 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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