Memantine Treatment for Obsessive-compulsive Disorder and Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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 individuals with OCD and individuals with GAD. Because glutamatergic hyperactivity in frontal and frontal-subcortical circuits may play a role in the symptomatic expression of OCD, and possibly GAD, agents that reduce glutamatergic neurotransmission should provide unique anti-stress and anti-obsessional benefits. Memantine is a specific, uncompetitive antagonist at the NMDA receptor that blocks sustained activation of the NMDA receptor by high concentrations of glutamate under pathological conditions but rapidly leaves the NMDA channel upon transient physiological activation by low concentrations of glutamate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Saban Family Foundation
• Treatments: Memantine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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