Pattern Separation in Major Depressive Disorder

ConditionMajor Depressive Disorder (MDD)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-50

SponsorJeffrey Miller

About this trial

This study seeks to examine the effects of treatment with a selective serotonin reuptake inhibitor (SSRI), escitalopram, a first-line treatment for depression, in combination with placebo or with extended-release memantine, on neuropsychological function, regional brain activity assessed by functional magnetic resonance imaging, and depressive symptoms, in participants with Major Depressive Disorder. Escitalopram is administered in an open-label fashion in this study; extended release memantine is administered in a double-blind, randomized, placebo-controlled manner.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-50

Current diagnosis of MDD without psychotic features assessed within three weeks of study enrollment

17-item Hamilton Depression Rating Scale score ≥17 assessed within 3 weeks of study enrollment

Using an effective form of contraception at study enrollment and agrees to continue throughout study participation for individuals of child-bearing potential

Disqualifiers

Currently taking an antidepressant medication at study enrollment

Pregnant or breastfeeding at time of enrollment

Evidence of current unstable medical illness, including liver or renal impairment, or unstable cardiovascular or respiratory illness

QTc interval greater than 500 ms

Trial design

Design model

Parallel

Treatments tested in this trial

SSRI (escitalopram or sertraline)
Drug
11 weeks of open-label treatment with an SSRI, of which the last 6 weeks are augmented with memantine vs placebo. Primary SSRI for the study is escitalopram. In cases of prior intolerance or non-response to escitalopram, individuals will be treated with sertraline instead of escitalopram.
Extended-Release Memantine
Drug
6 weeks of treatment with extended-release memantine as augmentation to ongoing escitalopram treatment
Placebo
Drug
6 weeks of treatment with placebo as augmentation to ongoing escitalopram treatment

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: SSRI + MemantineExperimental treatment 2 interventions

Group B: SSRI + PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Pattern Separation Performance

Participants will complete a pattern separation task

Time frame

At baseline (week 0) and after completing the medication trial (week 11)

Secondary outcomes

Depression Severity

Depression severity will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS)

Time frame

At screening, baseline (week 0) and after completing the medication trial (week 11)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jeffrey Miller

Lead sponsor

New York State Psychiatric Institute

Sponsor institution

Source ClinicalTrials.gov

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