NCT00985933CompletedEarly Phase 1
A Single Center, Double-Blind, Randomized, Double Dummy, Placebo-Controlled, Three-Period Crossover Study to Assess the Effects of a mGluR2/3 Positive Allosteric Modulator [AZD8529] Upon Ketamine-Induced Cortical Stimulation and Impairment of Working-Memory Related Activation of the Prefrontal Cortex
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- fMRI
Study Overview
Brief Summary
The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Right handed
- •12th grade education or equivalent
- •Able to read and write English as primary language
Exclusion Criteria
- •History of head injury
- •Substance abuse or dependence
- •History of claustrophobia
Arms & Interventions
1
Experimental
180 mg of AZD8529
Intervention: Placebo to match AZD8529 (Drug)
1
Experimental
180 mg of AZD8529
Intervention: AZD8529 (Drug)
2
Experimental
50 mg AD8529
Intervention: AZD8529 (Drug)
2
Experimental
50 mg AD8529
Intervention: Placebo to match AZD8529 (Drug)
3
Placebo Comparator
Placebo
Intervention: AZD8529 (Drug)
3
Placebo Comparator
Placebo
Intervention: Placebo to match AZD8529 (Drug)
Outcomes
Primary Outcomes
fMRI
Time Frame: 3
Ketamine Infusion
Time Frame: 3
Secondary Outcomes
- Clinician Administered Dissociative States Scale (CADSS)
- Positive and Negative Syndrome Scale (PANSS)
- Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male AdultsKetamine-Induced Brain Activity ChangesPsychotic-like SymptomsNCT01892189Takeda27
Completed
Phase 2
Ketamine for the Treatment of Opioid Use Disorder and DepressionOpioid-use DisorderOpioid AbuseDepressionNCT04177706Medical University of South Carolina21
Completed
Phase 1
Double-Blind Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD)DepressionNCT02911597Stanford University16
Recruiting
Phase 3
Investigation of the effect of Ketamine in comparison with Dexmedetomidine dose in pain management and postoperative complications of orthopedicsfemoral fractureIRCT20161014030294N5Arak University of Medical Sciences70
Completed
Phase 3
Pain Medicine for Wound Care ProceduresWound CarePain IntensityHyperalgesiaNauseaVomitingHallucinationsNCT00701909University of California, San Francisco12