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

NCT00411398 | Completed Phase 3 Results

• 2 other identifiers: NAM-MD-46IRB # 5343
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

General Anxiety Disorder, Social Anxiety Disorder

Keywords

Anxiety, SNRI, SSRI,GAD,SAD

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Scale

  Standard Clinical Depression Rating Scale. Clinician administered. Scale units are points/numbers. Possible range is 0 to 44 with the latter signifying more severe anxiety

  10 wk

Study Arms (1)

Memantine 5-20mg/d flexible dose

EXPERIMENTAL

Memantine tablets 5-20mg/d flexible dose

Drug: Namenda/Memantine

Interventions

Namenda/Memantine DRUG

5mg tablets, 1-4 tabs by mouth per day

Memantine 5-20mg/d flexible dose

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• The patient has an active substance misuse disorder
• The patient is a significant risk of suicide
• The patient has recently started psychotherapy or counseling (within last 6 weeks)
• 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.
• The patient has previously participated in any clinical study are has been treated with memantine or venlafaxine XR.
• The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial.
• The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
• 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.
• The patient has a clinically significant deviation from normal in the physical examination.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University Psychiatry Dept.

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Phobia, Social; Anxiety Disorders

Interventions

Memantine

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Thomas Schwartz
• Organization: SUNY Upstate

schwartt@upstate.edu

3154643166

Study Officials

• Thomas L. Schwartz, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 14, 2006
• Study Start: December 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 10, 2014
• Results First Posted: December 10, 2014

Record last verified: 2014-12

Locations

US (1)