NCT00985933

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1 healthy

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 4, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

September 25, 2009

Last Update Submit

May 3, 2011

Conditions

HealthyMemory Impairment

Keywords

Healthy normal volunteers

Outcome Measures

Primary Outcomes (2)

  • fMRI

    3

  • Ketamine Infusion

    3

Secondary Outcomes (3)

  • Clinician Administered Dissociative States Scale (CADSS)

  • Positive and Negative Syndrome Scale (PANSS)

  • Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events

Study Arms (3)

1

EXPERIMENTAL

180 mg of AZD8529

Drug: AZD8529Drug: Placebo to match AZD8529

2

EXPERIMENTAL

50 mg AD8529

Drug: AZD8529Drug: Placebo to match AZD8529

3

PLACEBO COMPARATOR

Placebo

Drug: AZD8529Drug: Placebo to match AZD8529

Interventions

AZD8529DRUG

6 capsules by mouth 1 time 12 to 24 prior to assessments

123
Placebo to match AZD8529DRUG

6 capsules by mouth 1 time 12 to 24 hours prior to assessments

123

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Right handed
  • th grade education or equivalent
  • Able to read and write English as primary language

You may not qualify if:

  • History of head injury
  • Substance abuse or dependence
  • History of claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

New Haven, Connecticut, United States

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

AZD8529

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Krystal

    Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 29, 2009

Study Start

February 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 4, 2011

Record last verified: 2011-05

Locations

US(1)