NCT00986531

Brief Summary

The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Nov 2009

Typical duration for phase_1 schizophrenia

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 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

1.9 years

First QC Date

September 29, 2009

Last Update Submit

October 31, 2011

Conditions

Schizophrenia

Keywords

schizophreniaearly phase trials

Outcome Measures

Primary Outcomes (2)

  • Functional magnetic resonance imaging (fMRI)

    1 fMRI on Day 4; 1 fMRI on Day 21

  • Computerized neurocognitive tests

    1 on Day -1; 1 on Day 1 and on Day 21

Secondary Outcomes (4)

  • Positive and Negative Syndrome Scale (PANSS)

    Day-1; Day 4; Day 17; Day 21

  • Electroencephalography (EEG)

    Day 4; Day 21

  • Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,

    Labs at screening and on Days -1, 4, 17, 21, and 35; ECG at screening and Day 35; Physical Exam at screening and Day 35; Vital signs at screening and Days -1,4, 17, 21, and 35

  • Suicidality assessment, collection of adverse events

    Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35

Study Arms (2)

1

EXPERIMENTAL

80 mg AZD8529

Drug: AZD8529

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo to match AZD8529

Interventions

AZD8529DRUG

2 capsules by mouth for 3 days

1
Placebo to match AZD8529DRUG

2 capsules by mouth for 3 days

2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder

You may not qualify if:

  • ECT in the last 6 months
  • Substance abuse or dependence
  • History of claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

AZD8529

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Raquel Gur

    Hospital of the University of Pennsylvania, Dept of Psychiatry, Neuropsychiatry Section

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations

US(1)