The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00985933
First received: September 25, 2009
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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).


Condition Intervention Phase
Healthy
Memory Impairment
Drug: AZD8529
Drug: Placebo to match AZD8529
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • fMRI [ Time Frame: 3 ] [ Designated as safety issue: No ]
  • Ketamine Infusion [ Time Frame: 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician Administered Dissociative States Scale (CADSS)
  • Positive and Negative Syndrome Scale (PANSS)
  • Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
180 mg of AZD8529
Drug: AZD8529
6 capsules by mouth 1 time 12 to 24 prior to assessments
Drug: Placebo to match AZD8529
6 capsules by mouth 1 time 12 to 24 hours prior to assessments
Experimental: 2
50 mg AD8529
Drug: AZD8529
6 capsules by mouth 1 time 12 to 24 prior to assessments
Drug: Placebo to match AZD8529
6 capsules by mouth 1 time 12 to 24 hours prior to assessments
Placebo Comparator: 3
Placebo
Drug: AZD8529
6 capsules by mouth 1 time 12 to 24 prior to assessments
Drug: Placebo to match AZD8529
6 capsules by mouth 1 time 12 to 24 hours prior to assessments

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985933

Locations
United States, Connecticut
Research Site
New Haven, Connecticut, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: John Krystal Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00985933     History of Changes
Other Study ID Numbers: D2285M00015
Study First Received: September 25, 2009
Last Updated: May 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Healthy normal volunteers

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014