Trial Outcomes & Findings for An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder (NCT NCT01038128)

NCT ID: NCT01038128

Last Updated: 2015-05-04

Results Overview

Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: Baseline to 12 weeks
• Results posted on: 2015-05-04

Participant Flow

Participant milestones

Measure	Memantine Memantine, 10-40 mg daily
Overall Study STARTED	5
Overall Study Baseline Visit	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Memantine Memantine, 10-40 mg daily
Overall Study Lack of Efficacy	1
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

An Open Label Trial of Memantine in the Treatment of Bulimia Nervosa and Body Dysmorphic Disorder

Baseline characteristics by cohort

Measure	Memantine n=5 Participants Memantine, 10-40 mg daily
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.5 years STANDARD_DEVIATION 18.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: One subject completed. The remaining two subjects' last observation was carried forward.

Number of self-reported binge eating and self-induced vomiting episodes during the week prior to the Baseline and Endpoint Visits.

Outcome measures

Measure	Memantine n=3 Participants Number of Binge Eating and Purging Episodes at Baseline and Endpoint
Number of Binge Eating and Self-induced Vomiting Episodes Binge Eating Baseline	20.67 number of episodes Standard Deviation 14.74
Number of Binge Eating and Self-induced Vomiting Episodes Binge Eating Endpoint	31.33 number of episodes Standard Deviation 35.25
Number of Binge Eating and Self-induced Vomiting Episodes Purging Baseline	21.67 number of episodes Standard Deviation 27.30
Number of Binge Eating and Self-induced Vomiting Episodes Purging Endpoint	36.67 number of episodes Standard Deviation 54.93

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: One subject completed. The remaining two subjects' last observation was carried forward.

Ratings obtained from the self-induced vomiting and laxative misuse sections of the Eating Disorder Examination. The scale asks participants to calculate discreet episodes of self-induced vomiting and laxative misuses over the period of four weeks. Generally, the value obtained is the number of occurrences. However, in cases where the number of occurrences was too great to be calculated, the number "777" was used. The scale is therefore open-ended, with higher numbers coinciding with a greater number of episodes.

Outcome measures

Measure	Memantine n=3 Participants Number of Binge Eating and Purging Episodes at Baseline and Endpoint
Ratings of Eating Pathology Baseline Data	101.33 units on a scale Standard Deviation 71.07
Ratings of Eating Pathology Endpoint Data	38.67 units on a scale Standard Deviation 30.27

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: One subject completed. The remaining two subjects' last observation was carried forward.

Disorder severity is measured based on the Clinical Global Impression Scale. The scale ranges from 1 unit (Not at all ill) to 7 units (extremely ill).

Outcome measures

Measure	Memantine n=3 Participants Number of Binge Eating and Purging Episodes at Baseline and Endpoint
Clinical Global Impression Scale Baseline Data	5 units on a scale Standard Deviation 0
Clinical Global Impression Scale Endpoint Data	4 units on a scale Standard Deviation 1.41

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: One subject completed. The remaining two subjects' last observation was carried forward.

The scale ranges from 0 to 91 units, with 0 representing the least ill and 91 representing the most ill.

Outcome measures

Measure	Memantine n=3 Participants Number of Binge Eating and Purging Episodes at Baseline and Endpoint
Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale Baseline Data	57.67 units on a scale Standard Deviation 0.58
Body Dysmorphic Disorder Version of the Yale Brown Obsessive Compulsive Scale Endpoint Data	48.67 units on a scale Standard Deviation 6.51

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: This scale was only administered to participants with Body Dysmorphic Disorder. No participants with BDD completed the Baseline Visit and, therefore, no results were available to analyze.

The range for this scale is 0 to 28 units, with 0 representing the least ill and 28 representing the most ill.

Outcome measures

Outcome data not reported

Adverse Events

Memantine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Memantine n=3 participants at risk Memantine, 10-40 mg daily
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1
General disorders Headache	33.3% 1/3 • Number of events 1
Eye disorders Pain when closing eyes	33.3% 1/3 • Number of events 1
Eye disorders Constant eye pressure	33.3% 1/3 • Number of events 1
Eye disorders Eye pain	33.3% 1/3 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1

Additional Information

Study Coordinator

McLean Hospital

Phone: 617-855-2984

Email: eryan@mclean.harvard.edu

Results disclosure agreements

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