NCT00264238

Brief Summary

The purpose of this study is to determine whether memantine is safe and effective when used as an augmentation to standard treatment for Obsessive-Compulsive Disorder (OCD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

March 7, 2017

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

December 9, 2005

Results QC Date

November 7, 2016

Last Update Submit

April 19, 2017

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)

    The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity

    Baseline and 12 weeks

Secondary Outcomes (1)

  • Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)

    Baseline and 12 weeks

Study Arms (1)

Memantine open label

EXPERIMENTAL

All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.

Drug: Memantine

Interventions

MemantineDRUG

pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder

Also known as: Namenda
Memantine open label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • suffering from OCD
  • Y-BOCS score of 18 or greater
  • taking a therapeutic dose of an anti-OCD medication specified in the protocol

You may not qualify if:

  • diagnosed with a mental disorder other than OCD
  • taking tiagabine or pregabalin
  • having had a previous trial of memantine
  • receiving therapy for OCD
  • substance abuse in the last 6 months
  • personality disorders sufficiently severe to interfere with study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Aboujaoude E, Barry JJ, Gamel N. Memantine augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. J Clin Psychopharmacol. 2009 Feb;29(1):51-5. doi: 10.1097/JCP.0b013e318192e9a4.

    PMID: 19142108RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Limitations and Caveats

This study is limited by its open-label design, small size, and the presence of comorbidities and concurrent psychotropic medications

Results Point of Contact

Title
Dr John Barry, Professor
Organization
Stanford University School of Medicine, Dept of Psychiatry
jbarry@stanford.edu
(650) 725-5588

Study Officials

  • John J Barry, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

January 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 30, 2017

Results First Posted

March 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)