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Phase 3 Completed N=15 Treatment

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

General Anxiety Disorder, Social Anxiety Disorder
Source: ClinicalTrials.gov NCT00411398 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Hamilton Anxiety Scale — 10.9 units on a scale

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Hamilton Anxiety Scale
10.9

Eligibility Criteria

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

  • Written informed consent is obtained.
  • The patient is English-speaking and18 through 64 years of age inclusive.
  • The patient meets the DSM-IV criteria for generalized anxiety disorder or social anxiety disorder as determined by the MINI and psychiatric evaluation.
  • 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
  • The patient has a total score of at least 10 on the HAM-A scale
  • The patient has a score of at least 5 on the HADS anxiety subscale score at the screening and baseline visits.
  • The patient has a CGI-S showing that anxiety symptom burden is impacting negatively on subject's life
  • 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.
  • 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.
  • 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:

  • Written informed consent is obtained.
  • The patient is English-speaking and18 through 64 years of age inclusive.
  • The patient meets the DSM-IV criteria for generalized anxiety disorder or social anxiety disorder as determined by the MINI and psychiatric evaluation.
  • 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
  • The patient has a total score of at least 10 on the HAM-A scale
  • The patient has a score of at least 5 on the HADS anxiety subscale score at the screening and baseline visits.
  • The patient has a CGI-S showing that anxiety symptom burden is impacting negatively on subject's life
  • 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.
  • 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.
  • The patient must be willing and able to comply with study restrictions and t
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00411398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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