Trial Outcomes & Findings for Memantine to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Major Depression (NCT NCT00186498)

NCT ID: NCT00186498

Last Updated: 2019-09-27

Results Overview

The California Verbal Learning Test Delayed Free Recall is a measure of episodic verbal learning and memory. These results are from the Free Recall subtest. In this test the subject must recall a list of 16 nouns after 20 minutes without cueing. It assesses auditory encoding, recall and recognition. Scores reflect the number of correct recall of the presented words, and scores are are then normalized by age. A higher score reflects better memory function.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2019-09-27

Participant Flow

Patients over age 18 who are referred for ECT for unipolar or bipolar depression were screened and enrolled. All patients receive right unilateral lead placements, and otherwise the entire procedure would be delivered as per usual clinical care at our institution. Patients who sign an informed consent for this study were screened for eligibility.

Participant milestones

Measure	Memantine Patients receiving memantine for 2 days before ECT for a total of 30 days	Placebo Patients receiving placebo for 2 days before ECT for a total of 30 days
Overall Study STARTED	6	5
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Memantine to Reduce Neurocognitive Deficits Following Unilateral ECT for the Treatment of a Major Depression

Baseline characteristics by cohort

Measure	Memantine n=6 Participants Patients receive memantine starting the day before ECT begins and while receiving ECT memantine: Memantine vs placebo	Placebo n=5 Participants Patients receive placebo starting the day before ECT begins and while receiving ECT memantine: Memantine vs placebo	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.3 years STANDARD_DEVIATION 13.1 • n=5 Participants	42.5 years STANDARD_DEVIATION 11.3 • n=7 Participants	41.0 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: The subjects enrolled in the study had signed a consent to receive ECT treatment.

The California Verbal Learning Test Delayed Free Recall is a measure of episodic verbal learning and memory. These results are from the Free Recall subtest. In this test the subject must recall a list of 16 nouns after 20 minutes without cueing. It assesses auditory encoding, recall and recognition. Scores reflect the number of correct recall of the presented words, and scores are are then normalized by age. A higher score reflects better memory function.

Outcome measures

Measure	Memantine n=6 Participants Patients are randomized 1:1, memantine treatment is for 2 days before ECT for a total of 30 days	Placebo n=5 Participants Patients are randomized 1:1, placebo treatment is for 2 days before ECT for a total of 30 days
Memantine Effect on CVLT Long Term Recall After Right Unilateral ECT Treatment.	10.17 units on a scale Standard Deviation 5.565	6.67 units on a scale Standard Deviation 4.590

Adverse Events

Memantine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hugh Brent Solvason

Stanford University

Phone: 650 776 4793

Email: solvason@stanford.edu

Results disclosure agreements

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