CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
Intravenous ketamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03237286
NCT03237286Phase 2Completed

Testing a Synergistic, Neuroplasticity-Based Intervention for Depressive Neurocognition

Rebecca Price·interventional·Posted Aug 2, 2017·Updated Mar 19, 2024

In Brief

A Phase 2 clinical trial evaluating Intravenous ketamine and Computer-based Cognitive Training for Depression. Completed, enrolled 154 participants across 1 site.

Detailed Summary

This study has two aims: 1) to characterize the effects of intravenous ketamine on neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic intervention for depression combining intravenous ketamine with neurocognitive training. Three of the primary outcomes listed (fMRI functional connectivity; Implicit Association Test; cognitive flexibility testing) pertain to Aim 1. For Aim 2, one primary clinical outcome (MADRS, a clinician-administered measure of depression severity) pertains to the acute (30-day) phase, while the QIDS (a self-report measure of depression severity) becomes the primary clinical outcome during the 12-month naturalistic follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 2, 2017
Enrollment StartDec 1, 2017
Primary CompletionOct 18, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.9 years ago

Interventions

Intravenous ketaminedrug

Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.

Computer-based Cognitive Trainingbehavioral

Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine "window of opportunity" might extend relief from depression.