Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression

This study has been completed.
Sponsor:
Collaborators:
Liebowitz, Michael R., M.D.
Pfizer
Information provided by (Responsible Party):
The Medical Research Network
ClinicalTrials.gov Identifier:
NCT00237666
First received: October 7, 2005
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Bipolar II Disorder
Major Depressive Episode
Drug: Ziprasidone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression

Resource links provided by NLM:


Further study details as provided by The Medical Research Network:

Primary Outcome Measures:
  • The Primary Efficacy Endpoint is the Comparison of Baseline and Week 8 Endpoint in the 17-item HAM-D Total Scores [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Hamilton Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-54, with higher scores indicating greater severity of symptoms.


Secondary Outcome Measures:
  • Mean Change From Baseline in the Hamilton Anxiety Scale (HAM-A) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Hamilton Anxiety Rating Scale, measuring anxiety symptoms; possible total scores ranging from 0-30, with higher scores indicating greater severity of anxiety.

  • Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Montgomery-Åsberg Depression Rating Scale, measuring depression symptoms; possible total scores ranging from 0-60, with higher scores indicating greater severity of depression.

  • Percentage of Subjects With Clinical Global Inventory (CGI) Global Improvement Score of 1 or 2 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

    Clinical Global Impression of Improvement scale: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement.

    18 subjects (60%) were responders (defined as having a CGI-I scores of 1 or 2 at Week 8/study endpoint) by the end of the trial.


  • Mean Change From Baseline in the CGI-Severity of Illness (CGI-S) Score at Study Endpoint [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Clinical Global Impression of Severity scale: one item, measuring overall severity of illness; possible scores range from 1-7, with higher scores representing greater severity of illness.

  • Mean Change From Baseline in the Total Score of the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale consists of 14 items; possible scores range from 14-70 with higher scores indicating greater quality of life and satisfaction.

  • Mean Change From Baseline in the Total Score of the Beck Depression Inventory (BDI) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Beck Depression Inventory, self-rated scale measuring depression symptoms; possible total scores ranging from 0-63, with higher scores indicating greater severity of depression.


Enrollment: 30
Study Start Date: February 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ziprasidone
Ziprasidone monotherapy, 20-60 mg BID.
Drug: Ziprasidone
Ziprasidone 20-60 mg BID, taken orally.
Other Name: Geodon

Detailed Description:

Bipolar II disorder is largely unstudied, with much less known about its treatment in comparison to Bipolar I disorder. While established mood stabilizers treat and prevent subsequent episodes of hypomania, chronic or recurrent depressions are harder to treat or prevent. In general the treatment of depression in Bipolar II patients is often complicated and there is no clinical unanimity on what approaches to follow. Administration of proven antidepressants would seem most appropriate and are most often used, but their use often involves a number of difficulties. Among these are:

  • antidepressant efficacy is established for unipolar patients and extrapolation to Bipolar II patients is done without empirical support
  • Bipolar II patients can have switches into hypomanic behavior in response to antidepressant treatment given as monotherapy
  • even when mood stabilizers are concomitantly given, switches to hypomanic states still occur when antidepressants are added
  • antidepressants can cause cycle acceleration or induce rapid cycling when given to Bipolar II patients
  • non-response and loss of response are common reactions to antidepressants in Bipolar II patients

This study will also assess the tolerability of Geodon in the treatment of patients diagnosed with Bipolar II disorder who currently meet criteria for a Major Depressive Episode by examining the incidence of adverse events and the withdrawal rate due to adverse events.

This will be an open-label study. Subjects will be treated for 8 weeks with Geodon, starting at a dose of 20 mg twice per day. The maximum dose will be 60 mg twice per day. Subjects will have a physical exam, electrocardiogram (ECG), standard laboratory tests and a urine drug screen at the screen visit.

Efficacy evaluations will include 17-item Hamilton Depression Scale, Hamilton Anxiety Scale (HAM-D), Montgomery-Asberg Depression Rating Scale, and the Young Mania Rating Scale. Social outcome will be measured with a quality-of-life scale (the Q-LES-Q). Overall efficacy will be rated using the Clinical Global Severity and Improvement Scales.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237666

Locations
United States, New York
Medical Research Network, L.L.C.
New York, New York, United States, 10024
United States, Texas
The Mech Center
Plano, Texas, United States, 75024
Sponsors and Collaborators
The Medical Research Network
Liebowitz, Michael R., M.D.
Pfizer
Investigators
Principal Investigator: Michael R Liebowitz, MD Medical Research Network, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: The Medical Research Network
ClinicalTrials.gov Identifier: NCT00237666     History of Changes
Other Study ID Numbers: 04-3945-A 01
Study First Received: October 7, 2005
Results First Received: November 20, 2012
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The Medical Research Network:
Bipolar II Disorder
Major Depressive Episode

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014