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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00411398
Recruitment Status : Completed
First Posted : December 14, 2006
Results First Posted : December 10, 2014
Last Update Posted : December 10, 2014
Information provided by (Responsible Party):
Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: General Anxiety Disorder, Social Anxiety Disorder
Intervention: Drug: Namenda/Memantine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
subjects were recruited easily by radio and newspaper advertisements

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Memantine Memantine tablets

Participant Flow:   Overall Study

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Memantine Memantine tablets

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   0 
[Units: Participants]
Female   11 
Male   4 
Region of Enrollment 
[Units: Participants]
United States   15 

  Outcome Measures

1.  Primary:   Hamilton Anxiety Scale   [ Time Frame: 10 wk ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Thomas Schwartz
Organization: SUNY Upstate
phone: 3154643166

Responsible Party: Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University Identifier: NCT00411398     History of Changes
Other Study ID Numbers: NAM-MD-46
IRB # 5343
First Submitted: December 12, 2006
First Posted: December 14, 2006
Results First Submitted: September 6, 2012
Results First Posted: December 10, 2014
Last Update Posted: December 10, 2014