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A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression

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ClinicalTrials.gov Identifier: NCT00141271
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : March 24, 2009
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Brief Summary:
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Geodon (Ziprasidone) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral Ziprasidone in Outpatients With Bipolar I Depression
Study Start Date : July 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Active Comparator: 20-40mg BID arm Drug: Geodon (Ziprasidone)
Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial

Active Comparator: 60-80mg bid arm Drug: Geodon (Ziprasidone)
Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial

Placebo Comparator: Placebo Drug: Placebo
Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial




Primary Outcome Measures :
  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score [ Time Frame: Baseline to 6 weeks ]
    Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.


Secondary Outcome Measures :
  1. Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score [ Time Frame: Baseline to 6 weeks ]
    Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60

  2. Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score [ Time Frame: Baseline to 6 weeks ]
    Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.

  3. Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF) [ Time Frame: Baseline, 6 Weeks LOCF ]
    Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, & occupational functioning; 100=normal and 0=greatest abnormality

  4. Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12 [ Time Frame: Baseline to 6 weeks ]
    Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal)

  5. Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7 [ Time Frame: Baseline to 6 weeks ]
    Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.

  6. Change in Hamilton Depression (HAM-D 17) Total Score [ Time Frame: Baseline to 6 weeks ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52.

  7. Change in Hamilton Anxiety Rating (HAM-A) [ Time Frame: Baseline to 6 weeks ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56.

  8. Change in Total Score of Young Mania Rating Scale (YMRS) [ Time Frame: Baseline to 6 weeks ]
    Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 0 to 4 for 7 items and 0 to 8 for 4 items; 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.

  9. Change in Assessment of Global Clinical Severity of Symptoms (CGI-S) [ Time Frame: Baseline to 6 weeks ]
    Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill

  10. Change in Global Clinical Improvement of Symptoms (CGI -I) [ Time Frame: Baseline to 6 weeks ]
    Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse

  11. Change in Total Score in Hamilton Depression (HAM-D 25) [ Time Frame: Baseline to 6 Weeks ]
    Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72.

  12. Response as Measured by CGI-I Score Less Than or Equal to 2 [ Time Frame: Week 1 through Week 6 (endpoint) ]
    Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse

  13. Change in Sheehan Disability Scale (SDS) Total Score at Endpoint [ Time Frame: Baseline to Week 6 ]
    Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30.

  14. Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint [ Time Frame: Baseline to 6 Weeks ]
    Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80

  15. Change in Bech Melancholia Score [ Time Frame: Baseline to 6 Weeks ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24.

  16. Change in Anxiety/Somatizations Factor Total Score [ Time Frame: Baseline to 6 Weeks ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24.

  17. Change in Retardation Factor Scores [ Time Frame: Baseline to 6 Weeks ]
    Change is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16.

  18. Change in Sleep Disturbance Factor Score [ Time Frame: Baseline to 6 weeks ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12.

  19. Change in Verbal Memory Trial Performance Total Score at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall.

  20. Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall.

  21. Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall.

  22. Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall

  23. Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall

  24. Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall

  25. Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall

  26. Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall

  27. Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall

  28. Change in Digit Sequencing Task at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition.

  29. Change in Token Motor Task at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks

  30. Change in Verbal Fluency in Naming Categories at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition.

  31. Change in Verbal Fluency Controlled Word Association at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words

  32. Change in Symbol Coding at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition.

  33. Change in Tower of London Test at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition.

  34. Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition.

  35. Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint [ Time Frame: Baseline to 6 Weeks LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition

  36. Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint [ Time Frame: Baseline to Week 6 LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition

  37. Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint [ Time Frame: Baseline to Week 6 LOCF ]
    Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text Revision (DSM-IV-TR) (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

  • Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (298.9).
  • Subjects with other DSM-IV TR Axis I or Axis II disorder (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6 month period prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141271


Locations
Show Show 72 study locations
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00141271    
Other Study ID Numbers: A1281136
First Posted: September 1, 2005    Key Record Dates
Results First Posted: March 24, 2009
Last Update Posted: March 25, 2021
Last Verified: March 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
Bipolar I Disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents