MedDataX Logo

Trial Outcomes & Findings for Memantine Augmentation in Obsessive-Compulsive Disorder (NCT NCT00264238)

NCT ID: NCT00264238

Last Updated: 2017-05-30

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2017-05-30

Participant Flow

From February 2006 to February 2008, participants recruited from the Stanford School of Medicine Department of Psychiatry and Behavioral Sciences OCD clinic and through online adds. Subjects had to have had failed to respond to at least 12 weeks of treatment at an adequate and stable dose of an serotonin reuptake inhibitor (SRI) (YBOCS of GE 18)

Participant milestones

Participant milestones
Measure
Memantine Open Label
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. Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder
Overall Study
STARTED
15
Overall Study
COMPLETED
14
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Memantine Open Label
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. Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder
Overall Study
Protocol Violation
1

Baseline Characteristics

Memantine Augmentation in Obsessive-Compulsive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Memantine Open Label
n=14 Participants
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. Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder
Age, Continuous
37.3 years
STANDARD_DEVIATION 13.7 • n=93 Participants
Sex: Female, Male
Female
5 Participants
n=93 Participants
Sex: Female, Male
Male
9 Participants
n=93 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
Race (NIH/OMB)
White
14 Participants
n=93 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
Region of Enrollment
United States
14 participants
n=93 Participants
Yale-Brown Obsessive Compulsive Scale
27.4 units on a scale
STANDARD_DEVIATION 5 • n=93 Participants
Psychiatric comorbid condition
Participants with comorbid condition
8 participants
n=93 Participants
Psychiatric comorbid condition
Participants without comorbid condition
6 participants
n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 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

Outcome measures

Outcome measures
Measure
Responders: Memantine Open Label
n=6 Participants
Participants who respond to memantine as adjunctive therapy defined as Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI-I rating of "much" or "very much" improved.
Non-Responders: Memantine Open Label
n=8 Participants
Participants who did not respond to memantine as adjunctive therapy
Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)
At baseline
23.8 units on a scale
Standard Deviation 3.5
30 units on a scale
Standard Deviation 4.4
Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)
At end of treatment
13.0 units on a scale
Standard Deviation 4.3
28.8 units on a scale
Standard Deviation 4.7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a scale of 0 (no symptoms) to 6 (extreme symptoms) and items are summed. The overall score ranges from 0 to 60. Higher MADRS score indicates more severe depression.

Outcome measures

Outcome measures
Measure
Responders: Memantine Open Label
n=6 Participants
Participants who respond to memantine as adjunctive therapy defined as Y-BOCS decrease of greater than or equal to 25% from baseline and a CGI-I rating of "much" or "very much" improved.
Non-Responders: Memantine Open Label
n=8 Participants
Participants who did not respond to memantine as adjunctive therapy
Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)
Mean at baseline
11.8 units on a scale
Standard Deviation 6.6
14.9 units on a scale
Standard Deviation 8.4
Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)
Mean at end of treatment
5.0 units on a scale
Standard Deviation 6.5
14.6 units on a scale
Standard Deviation 10.5

Adverse Events

Memantine Open Label

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Memantine Open Label
n=14 participants at risk
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. Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder
Gastrointestinal disorders
Nausea
21.4%
3/14 • Number of events 3 • 12 weeks of study medication dosing
Nervous system disorders
Headache
21.4%
3/14 • Number of events 3 • 12 weeks of study medication dosing
Psychiatric disorders
Somnolence
7.1%
1/14 • Number of events 1 • 12 weeks of study medication dosing
General disorders
Night sweats
7.1%
1/14 • Number of events 1 • 12 weeks of study medication dosing
Investigations
Light-headedness
7.1%
1/14 • Number of events 1 • 12 weeks of study medication dosing
Nervous system disorders
Fatigue
7.1%
1/14 • Number of events 1 • 12 weeks of study medication dosing

Additional Information

Dr John Barry, Professor

Stanford University School of Medicine, Dept of Psychiatry

Phone: (650) 725-5588

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place