NCT00034801

Brief Summary

This is a research study comparing the safety and efficacy of two active study medications

Trial Health

87
On Track

Trial Health Score

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

Enrollment
378

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Sep 2001

Shorter than P25 for phase_4 depression

Geographic Reach
1 country

30 active sites

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

September 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

July 19, 2006

Status Verified

July 1, 2006

First QC Date

May 2, 2002

Last Update Submit

July 18, 2006

Conditions

Keywords

DepressionComorbid DepressionSchizophreniaSchizoaffective Disorder

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female subjects 18-60 years of age
  • Female subjects of childbearing potential must be using a medically accepted means of contraception
  • Each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol
  • Subjects must be considered reliable

You may not qualify if:

  • Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry
  • Female subjects who are either pregnant or nursing
  • Uncorrected hypothyroidism or hyperthyroidism
  • Narrow-angle glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Tuscaloosa, Alabama, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

Chula Vista, California, United States

Location

Unknown Facility

Lafayette, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Poway, California, United States

Location

Unknown Facility

Rosemeade, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

New Britain, Connecticut, United States

Location

Unknown Facility

Winter Park, Florida, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Prairie Village, Kansas, United States

Location

Unknown Facility

Gaithersburg, Maryland, United States

Location

Unknown Facility

Mount Pleasant, Michigan, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Lincoln, Nebraska, United States

Location

Unknown Facility

Clementon, New Jersey, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Staten Island, New York, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Sioux Falls, South Dakota, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

El Paso, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

DepressionSchizophreniaPsychotic Disorders

Interventions

Olanzapineziprasidone

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

September 1, 2001

Study Completion

March 1, 2003

Last Updated

July 19, 2006

Record last verified: 2006-07

Locations