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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: State University of New York - Upstate Medical University
• Treatments: Memantine; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:Patients are included in the study if all of the following criteria are met:

1. Written informed consent is obtained.

2. The patient is English-speaking and18 through 64 years of age inclusive.

3. The patient meets the DSM-IV criteria for generalized anxiety disorder or social anxiety disorder as determined by the MINI and psychiatric evaluation.

4. The patient is currently taking venlafaxine XR- SNRI or a SSRI medication for ≥ 6 weeks and on a stable, adequate therapeutic dosage and remains anxiety symptomatic

5. The patient has a total score of at least 10 on the HAM-A scale

6. The patient has a score of at least 5 on the HADS anxiety subscale score at the screening and baseline visits.

7. The patient has a CGI-S showing that anxiety symptom burden is impacting negatively on subject's life

8. The patient is in good health as determined by a medical and psychiatric history, medical examination, and cannot have major medical illness that would jeopardize patient health during the study.

9. Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen). Women must be given a pregnancy test (ßHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative.

10. The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Patients are included in the study if all of the following criteria are met:

1. Written informed consent is obtained.

2. The patient is English-speaking and18 through 64 years of age inclusive.

3. The patient meets the DSM-IV criteria for generalized anxiety disorder or social anxiety disorder as determined by the MINI and psychiatric evaluation.

4. The patient is currently taking venlafaxine XR- SNRI or a SSRI medication for ≥ 6 weeks and on a stable, adequate therapeutic dosage and remains anxiety symptomatic

5. The patient has a total score of at least 10 on the HAM-A scale

6. The patient has a score of at least 5 on the HADS anxiety subscale score at the screening and baseline visits.

7. The patient has a CGI-S showing that anxiety symptom burden is impacting negatively on subject's life

8. The patient is in good health as determined by a medical and psychiatric history, medical examination, and cannot have major medical illness that would jeopardize patient health during the study.

9. Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen). Women must be given a pregnancy test (ßHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative.

10. The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.

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Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met:

1. The patient is on more than one antidepressant or anxiolytic as a standing dose. PRN use of anxiolytic or sleeping agents may be continued at discretion of the investigator

2. The patient has an active substance misuse disorder

3. The patient is a significant risk of suicide

4. The patient has recently started psychotherapy or counseling (within last 6 weeks)

5. The patient has other psychiatric Axis-I disorders as a principal diagnosis (except generalized anxiety) within 6 months of screening and baseline visits; any history of OCD, psychotic disorder, bipolar disorder, mental retardation, or clear personality disorder. Patient may have a co-morbid substance misuse, depressive or anxiety disorder if it has been in remission for at least 6 months prior to screening visit.

6. The patient has previously participated in any clinical study are has been treated with memantine or venlafaxine XR.

7. The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial.

8. The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).

9. The patient is unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator.

10. The patient has a clinically significant deviation from normal in the physical examination.

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