NCT00191555|CompletedPhase 4

Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment

Double-Blind Long-term Study Comparing the Efficacy and Safety of Olanzapine Versus Haloperidol in Patients With Schizophrenia Previously Stabilized With Conventional Antipsychotic Treatment

Eli Lilly and Company ClinicalTrials.gov

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2 other identifiers

6589F1D-FP-S029

Study Type

interventional

Target

360

Locations

1 country

Sites

Timeline

RegisteredSep 2005

StartedAug 2003

CompletionMay 2006

Brief Summary

The objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.

Trial Health

On Track

Trial Health Score

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

Enrollment

360

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline

Completed

Started Aug 2003

Geographic Reach

1 country

62 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

2.8 years study duration

Study Start

First participant enrolled

August 1, 2003

Completed

2.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed

Last Updated

June 12, 2012

Status Verified

July 1, 2006

First QC Date

September 12, 2005

Last Update Submit

June 8, 2012

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (5)

The primary efficacy measure is defined as relapse. Relapse is defined by the presence of at least one of the following criteria:
Psychiatric hospitalization.
A 25% increase in the total score on the PANSS scale (Kay SR et al. 1987) in relation to the score obtained at the baseline visit (Visit 2).
A major deterioration in clinical condition, defined by a score of 6 ("much worse") or 7 ("very much worse") on the CGI-I scale (Clinical Global Impression-Improvement)
Suicide attempt requiring medical treatment and/or jeopardizing vital prognosis (self-mutilation, ingestion of a toxic substance, defenestration, self-mutilation with suicidal intent).

Secondary Outcomes (8)

The following secondary efficacy criteria will be measured at the times indicated in the Schedule of Events
Positive and negative symptom scale : PANSS
Clinical global impression scale: CGI [Clinical global impression-severity of illness (CGI-S); Clinical global impression-improvement of illness (CGI-I); Clinical Global Impression scale - Psychic distress]
Schizophrenic Communication Disorder Rating Scale: SCD
Social Interactions measurement tools
+3 more secondary outcomes

Interventions

olanzapineDRUG

haloperidolDRUG

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Schizophrenic patient meeting the DSM-IV diagnostic criteria more than one year ago and treated with antipsychotic for at least 1 year.
Outpatient (or patient admitted to hospital for social or logistic reasons).
Patient receiving a stable dose of the same conventional antipsychotic for at least 8 weeks before visit 1.
Patient presenting a PANSS score equal or greater than 49 at Visit 2.
Patient considered by the investigator as possible candidates for a switch, owing to inadequate efficacy or poor safety of the current treatment.

You may not qualify if:

Patient presenting a schizophreniform or a schizo-affective disorder according to the DSM-IV diagnostic criteria, or any other disorder from Axis I of the DSM-IV, or a disorder from Axis II (limit personality), substance dependence or substance abuse.
Administration of an atypical antipsychotic drug during the 8 weeks preceding V1.
History of resistance to antipsychotic drugs
Hospitalization in a psychiatric unit or in a psychiatric emergency department within the 8 weeks preceding the beginning of the study.
Presence of serious unstable disease, such as a fatal outcome or hospitalization in an intensive care unit, is foreseeable within a period of 6 months.

Contact the study team to confirm eligibility.