Status:
COMPLETED
Memantine Treatment for Obsessive-compulsive Disorder and Generalized Anxiety Disorder
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Saban Family Foundation
Conditions:
Obsessive-Compulsive Disorder
Generalized Anxiety Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
The objective of this study was to obtain preliminary open-label data on the efficacy and tolerability of memantine, an anti-glutamatergic medication with a unique pharmacodynamic profile, in individu...
Detailed Description
Several case reports and an open-label trial have reported efficacy of anti-glutamatergic medications for the treatment of OCD. In an open-label trial of riluzole, a glutamate release inhibitor, seven...
Eligibility Criteria
Inclusion
- The subject is male or female outpatient between 18-64 years old.
- The subject meets DSM-IV criteria for Generalized Anxiety Disorder or Obsessive Compulsive Disorder as determined by the MINI.
- Sexually active female patients of childbearing potential must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception or abstinence. Female patients of childbearing potential must have a negative pregnancy test prior to receiving study drug.
- Written informed consent must be obtained from the subject prior to study participation.
- The subject is in good medical health or with chronic medical conditions which are currently stable.
- No current abuse of alcohol or other substance.
- The subject has a total score of 20 or more on the HARS or YBOCS at screening (for GAD and OCD, respectively)
- The subject has a Clinical Global Impression (CGI) Severity score of 4 or more at screening.
Exclusion
- The subject meets DSM-IV criteria for an Axis I diagnosis (other than GAD or OCD) as the primary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) as determined by the MINI.
- The subject is clinically judged by the investigator to be at risk for suicide or is acutely suicidal as objectively measured by the MINI and MSE.
- The subject is clinically judged by the investigator to be at risk for homicide or is acutely homicidal as objectively measured by the MINI and MSE.
- The subject has a psychiatric condition that would require inpatient, or partial psychiatric hospitalization.
- Seizure disorders.
- Significant history of medical disease (i.e. cardiovascular, hepatic (e.g. cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal, neurological, gastrointestinal, metabolic, hematological, endocrine, cancer with a metastatic potential or progressive neurological disorders) which could impair reliable participation in the trial or necessitate the use of medication not allowed by this protocol.
- The subject is pregnant, planning to become pregnant, or nursing. If a subject becomes pregnant, she will be discontinued immediately and followed appropriately.
- Concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.
- Current psychotherapeutic treatment except for treatment with Specific Reuptake Inhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline (Zoloft), Luvox (Fluvoxamine), and Citalopram. Potential subjects may remain on one of the SSRI medications provided that he or she has been on a stable dose for at least 4 weeks prior to entering this study; this dose remains stable throughout the remainder of this study; and it can be determined that this medication is not exacerbating the anxiety symptoms.
- History of poor compliance or in the Investigator's judgment patients any subject whose treatment as an outpatient would be clinically contraindicated
- The subject has attempted suicide one or more times within the past twelve months
- The subject has a Structured Hamilton Depression Rating Scale (SIGH-D) score above 38 which suggests a moderate to severe clinical level of depressive symptoms
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00674219
Start Date
May 1 2005
End Date
January 1 2008
Last Update
May 10 2019
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095