CClinicalTrials.gg
CompletedNCT00956085Updated Jun 21, 2017Results posted

Memantine Augmentation in Treatment-Resistant Adults With Obsessive-Compulsive Disorder

A Phase 2 interventional study of Memantine in Obsessive-Compulsive Disorder, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-06-21.

Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug memantine, which is thought to modulate the neurotransmitter glutamate, added to whatever other OCD medications they are taking.

Open label memantine will be titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine will be continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).

Read the detailed description

see above

02

Conditions studied

  • Obsessive-Compulsive Disorder

Keywords

  • OCD
03

In context

Compulsive Personality Disorder

367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.

This study's enrollment of 12 is below the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.

Browse Compulsive Personality Disorder studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-65 years old
  2. Primary Diagnosis of OCD
  3. Physically healthy and females must be using effective contraception
  4. At lease moderate OCD symptoms (Yale-Brown Obsessive-Compulsive Scale [YBOCS]score greater or equal to 16 prior to entering trial)
  5. Able to provide consent
  6. May be on or off selective reuptake inhibitor (SRI) medications

    1. Patients on an SRI medication will be included if the dose is stable and adequate (or if they don't want to increase their dose [e.g. side effects] and have a history of prior SRI or CBT treatment meeting criteria for adequate trial)
    2. Patients not on an SRI medication will be included if they they have failed at least 1 prior trial of standard OCD treatment (e.g. SRIs or CBT)

Exclusion criteria

Exclusion Criteria:

  1. Ongoing treatment with memantine
  2. Patients planning to start CBT during the study period or those who have started CBT within 8 weeks prior to study enrollment
  3. Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder.
  4. Current major depressive disorder (patients must be free of the disorder for three months prior to enrollment). Patients will be excluded if they are moderately to severely depressed, but if they are mildly to moderately depressed they will be included (Hamilton Depression Rating Scale must be \<18).
  5. Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors).
  6. Current eating disorder
  7. Females who are pregnant or nursing
  8. Severe renal insufficiency, severe hepatic impairment, or seizure disorder.
  9. Documented history of hypersensitivity or intolerance to memantine.
  10. Concomitant use of trimethoprim, N-methyl-D-aspartate receptor medications
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Memantine

    Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).

    Drug: Memantine

Interventions

  • DrugMemantine

    Open label memantine titrated in 5mg increments weekly to target dose of 10mg po bid for up to 6 weeks. Memantine was continued to 12 weeks in those with treatment response,13 either previous response to ketamine (≥ 35% Y-BOCS reduction 1 week after IV ketamine) or current response to memantine (≥ 35% Y-BOCS reduction from pre- to post-6 weeks of memantine).

    Also known as: Namenda

06

What researchers measure

Primary outcomes

  1. Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.

    Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.

    Time frame: Baseline and 6 weeks

07

Results

Posted May 10, 2017

Participant flow

Participant flow — Overall Study
MilestoneMemantine
Started12
Completed12
Not completed0

Outcome measures

PrimaryNumber of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.

Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.

Time frame:
Baseline and 6 weeks
Reported as:
Count of participants · Participants
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
ParticipantsMemantine
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Memantine—0/12 (0%)5/12 (41.7%)
Most frequent other events
Most frequent other events
EventMemantine
AnxietyPsychiatric disorders3/12
DizzinessNervous system disorders2/12

Baseline characteristics

Age, Continuous
Age, Continuous(years)Memantine
Mean34 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)Memantine
Female4
Male8
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Memantine
Hispanic or Latino2
Not Hispanic or Latino10
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Memantine
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American5
White6
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
09

References and documents

Publications

  • Rodriguez CI, Levinson A, Zwerling J, Vermes D, Simpson HB. Open-Label trial on the effects of memantine in adults with obsessive-compulsive disorder after a single ketamine infusion. J Clin Psychiatry. 2016 May;77(5):688-9. doi: 10.4088/JCP.15l10318. No abstract available. PubMed 27249077 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00956085
Lead sponsor
New York State Psychiatric Institute
Responsible party
Sponsor
First posted
Aug 11, 2009
Start date
Aug 2009
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
May 10, 2017
Last update
Jun 21, 2017

Study contacts

Carolyn I Rodriguez, M.D., Ph.D.
principal investigator · Stanford University
Helen B Simpson, MD, PhD
principal investigator · NYSPI-Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion