NCT00686998

Brief Summary

This study is designed to assess the effects of AZD 2624 in patients with schizophrenia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2 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

Study Start

First participant enrolled

May 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 23, 2011

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

10 months

First QC Date

May 28, 2008

Results QC Date

April 28, 2010

Last Update Submit

March 20, 2013

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline

    PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.

    Baseline, Day 28

Study Arms (3)

AZD2624

EXPERIMENTAL

AZD2624 40 mg

Drug: AZD2624

Olanzapine

OTHER

Olanzapine 15 mg

Drug: Olanzapine

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

AZD2624DRUG

Oral Suspension

AZD2624
OlanzapineDRUG

PO BID

Also known as: Zyprexa
Olanzapine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females of non-childbearing potential
  • Diagnosis of Schizophrenia

You may not qualify if:

  • Clinically relevant disease and /or abnormalities.
  • Alcohol or substance abuse not in remission
  • Enrollment in another investigational study within 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Rockville, Maryland, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

3-((methylsulfonyl)amino)-2-phenyl-N-(1-phenylpropyl)quinolin-4-carboxamideOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Gerard Lynch
Organization
Astrazeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Dhaval Desai, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 29, 2013

Results First Posted

June 23, 2011

Record last verified: 2013-03

Locations

US(1)