Memantine Treatment for Obsessive-compulsive Disorder and Generalized Anxiety Disorder

NCT00674219 | Completed Phase 3 Results

• 1 other identifier: 04-08-063-03
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Obsessive-Compulsive Disorder; Generalized Anxiety Disorder

Keywords

Obsessive-compulsive disorder; Generalized anxiety disorder; Memantine; Namenda

Outcome Measures

Primary Outcomes (1)

• Psychometric Scores

  Participants in the OCD group were rated using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), a standard measure of obsessive-compulsive disorder (OCD) severity in pharmacotherapy studies. It is administered by a trained rater. It comprises 10 items assessing OCD symptoms (e.g. time spent, degree of control, severity). Each item is scored on a scale from 0 (not present) to 4 (severe) \[total score range = 0-40\] over the previous week. The higher the number on the Y-BOCS, the more severe the symptoms. Participants in the GAD group were rated using the Hamilton Anxiety Rating Scale (HARS), a standard measure of anxiety severity in pharmacotherapy studies. It is administered by a trained rater. It comprises 14 items assessing anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  Baseline, 12 weeks

Study Arms (2)

OCD group

ACTIVE COMPARATOR

OCD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication.

Drug: Memantine

GAD group

ACTIVE COMPARATOR

GAD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication.

Drug: Memantine

Interventions

Memantine DRUG

Namenda 10mg BID for 12 weeks

Also known as: Namenda

GAD group; OCD group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Saban Family Foundation: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Feusner JD, Kerwin L, Saxena S, Bystritsky A. Differential efficacy of memantine for obsessive-compulsive disorder vs. generalized anxiety disorder: an open-label trial. Psychopharmacol Bull. 2009;42(1):81-93.

  PMID: 19204653 RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Generalized Anxiety Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Alexander Bystritsky MD PhD
• Organization: UCLA Department of Psychiatry

abystritsky@mednet.ucla.edu

(310) 206-5133

Study Officials

• Alexander Bystritsky, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor of Psychiatry and Biobehavioral Sciences

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 10, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)