Memantine Treatment for Obsessive-compulsive Disorder and Generalized Anxiety Disorder
Condition: Obsessive-Compulsive Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Intervention: Memantine
Intervention description: Namenda 10mg BID for 12 weeks
Intervention MeSH terms: Memantine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Obsessive-compulsive disorder; Generalized anxiety disorder; Memantine; Namenda

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.
    

Eligibility 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