NCT00237666

Brief Summary

The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2005

Typical duration for phase_4

Geographic Reach
1 country

2 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

February 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

June 19, 2013

Completed
Last Updated

June 19, 2013

Status Verified

May 1, 2013

Enrollment Period

3 years

First QC Date

October 7, 2005

Results QC Date

November 20, 2012

Last Update Submit

May 9, 2013

Conditions

Bipolar II DisorderMajor Depressive Episode

Keywords

Bipolar II DisorderMajor Depressive Episode

Outcome Measures

Primary Outcomes (1)

  • The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores

    Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.

    Week 8

Secondary Outcomes (6)

  • Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A)

    Week 8

  • Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale

    Week 8

  • Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2

    Week 8

  • Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint

    Week 8

  • Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

    Week 8

  • +1 more secondary outcomes

Study Arms (1)

Ziprasidone

EXPERIMENTAL

Ziprasidone monotherapy, 20-60 mg BID.

Drug: Ziprasidone

Interventions

ZiprasidoneDRUG

Ziprasidone 20-60 mg BID, taken orally.

Also known as: Geodon
Ziprasidone

Eligibility Criteria

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

You may qualify if:

  • patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania
  • patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration
  • minimum score of 18 on the 17-item HAM-D at screen and baseline

You may not qualify if:

  • patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia
  • patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture
  • Suicidal ideation or history that makes participation in a clinical trial unduly risky
  • unstable medical conditions or any abnormality in thyroid function
  • patients with a QTc of 450msec or greater on the initial ECG
  • patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics
  • the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment
  • patients with dementia or substance abuse in the last 6 months
  • pregnant or lactating women will be excluded, as will those not using adequate forms of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Research Network, L.L.C.

New York, New York, 10024, United States

Location

The Mech Center

Plano, Texas, 75024, United States

Location

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Results Point of Contact

Title
Dr. Michael Liebowitz
Organization
The Medical Research Network, LLC
MLiebowitz@MedicalResearchNetwork.com
(212) 595-5012

Study Officials

  • Michael R Liebowitz, MD

    Medical Research Network, L.L.C.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

February 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

June 19, 2013

Results First Posted

June 19, 2013

Record last verified: 2013-05

Locations

US(2)