NCT00767715

Brief Summary

The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
Last Updated

October 7, 2008

Status Verified

October 1, 2008

Enrollment Period

6 months

First QC Date

October 3, 2008

Last Update Submit

October 3, 2008

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP

    5 months

Secondary Outcomes (11)

  • Resource utilization Clinical Report Form (RUCRF)

    5 months

  • Disability free day assessment (DFDA)

    5 months

  • Medication compliance

    5 months

  • Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)

    5 months

  • Euro Qol instrument

    5 months

  • +6 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Patients will be given olanzapine

Drug: olanzapine

B

ACTIVE COMPARATOR

Patients will be given either haloperidol or zuclopentixol

Drug: haloperidolDrug: zuclopentixol

Interventions

olanzapineDRUG

physician determined dose, oral, daily, 5 months

Also known as: LY170053, Zyprexa
A
haloperidolDRUG

physician determined dose, oral, parenteral (\<= 3 days), daily, 5 months

B
zuclopentixolDRUG

physician determined dose, oral, parenteral (\<= 3 days), daily, 5 months

B

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of bipolar I disorder and currently display an acute manic or mixed episode (with or without psychotic features)
  • Patients must have a Y-MRS total score of greater or equal to 20 at visit 2
  • Patients must have experienced at least one manic or mixed episode prior to study enrollment
  • Female of childbearing potential must be using a medically accepted means of contraception, or practice sexual abstinence
  • Each patient must have a level of understanding sufficient to communicate intelligently with study personnel
  • Patients must be considered reliable
  • Each patient must understand the nature of the study and signed informed consent

You may not qualify if:

  • Female patients who are pregnant or lactating
  • Serious, unstable illnesses such that hospitalization for the disease is anticipated within 3 month or death is anticipated within 3 years
  • Uncorrected hypothyroidism or hyperthyroidism
  • Narrow-angle glaucoma
  • History of allergic reactions or intolerance to study medications
  • DSM-IV substance dependence within the past 30 days at the judgement of the investigator
  • Judged clinically to be at serious suicidal risk
  • Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to visit 2
  • Any patient treated with clozapine within 4 weeks prior to visit 2
  • Subjects who have received treatment with ECT within one month prior to visit 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Danderyd, Sweden

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

OlanzapineHaloperidolClopenthixol

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsButyrophenonesKetonesOrganic ChemicalsThioxanthenesSulfur CompoundsXanthenesHeterocyclic Compounds, 3-Ring

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 7, 2008

Study Start

October 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

October 7, 2008

Record last verified: 2008-10

Locations

SE(1)