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A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Placebo

Geodon (Ziprasidone)

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 NOS (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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ziprasidone 20 and 60mg

Placebo

Arm Description

For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).

Outcomes

Primary Outcome Measures

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.

Secondary Outcome Measures

Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score

Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)

Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 & 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF.

Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12

Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) & 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.

Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7

Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF.

Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 & 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF

Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)

Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 & 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF.

Change in Bech Melancholia Score

Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF.

Change in Anxiety/Somatizations Factor Total Score

Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF.

Change in Retardation Factor Scores

Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.

Change in Sleep Disturbance Factor Score

Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12.

Change in Hamilton Anxiety Rating (HAM-A)

Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56.

Change in Total Score of Young Mania Rating Scale (YMRS)

Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 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. Overall is average response Week 1 - 6.

Change in Global Clinical Severity of Symptoms (CGI-S)

Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill

Change in Global Clinical Improvement of Symptoms (CGI -I)

Change is observed value at each visit minus baseline value. 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

Change in Global Assessment of Functioning (GAF)

Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, & occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality.

Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score

Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80.

Change in Sheehan Disability Scale (SDS) Total Score

Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30.

Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject

Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits & degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)

Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating

Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits & degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF.

Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer

Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.

Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint

Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward.

Full Information

NCT ID

NCT00282464

First Posted

January 24, 2006

Last Updated

March 2, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00282464

Brief Title

A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.

Official Title

A Six-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone in Outpatients With Bipolar I Depression

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

February 2006 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

Bipolar I Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

392 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ziprasidone 20 and 60mg

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.

Intervention Type

Drug

Intervention Name(s)

Geodon (Ziprasidone)

Intervention Description

Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).

Primary Outcome Measure Information:

Title

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Description

Time Frame

Baseline to Week 6

Secondary Outcome Measure Information:

Title

Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score

Description

Time Frame

Baseline to Week 6

Title

Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Description

Time Frame

Baseline to Week 3, Week 6

Title

Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12

Description

Time Frame

Week 1 to Week 6

Title

Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7

Description

Time Frame

Week 3, Week 6

Title

Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score

Description

Time Frame

Baseline to Weeks 3, 6

Title

Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)

Description

Time Frame

Baseline to Weeks 3, 6

Title

Change in Bech Melancholia Score

Description

Time Frame

Baseline to Weeks 3, 6

Title

Change in Anxiety/Somatizations Factor Total Score

Description

Time Frame

Baseline to Weeks 3, 6

Title

Change in Retardation Factor Scores

Description

Time Frame

Baseline to Weeks 3, 6

Title

Change in Sleep Disturbance Factor Score

Description

Time Frame

Baseline to Weeks 3, 6

Title

Change in Hamilton Anxiety Rating (HAM-A)

Description

Time Frame

Baseline to Weeks 3, 6

Title

Change in Total Score of Young Mania Rating Scale (YMRS)

Description

Time Frame

Baseline to week 6

Title

Change in Global Clinical Severity of Symptoms (CGI-S)

Description

Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill

Time Frame

Baseline to week 6

Title

Change in Global Clinical Improvement of Symptoms (CGI -I)

Description

Time Frame

Baseline to Week 6

Title

Change in Global Assessment of Functioning (GAF)

Description

Time Frame

Baseline to week 6 (Endpoint)

Title

Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score

Description

Time Frame

Baseline to week 6 (endpoint)

Title

Change in Sheehan Disability Scale (SDS) Total Score

Description

Time Frame

Baseline to week 6 (endpoint)

Title

Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject

Description

Time Frame

Baseline to week 6 (endpoint)

Title

Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating

Description

Time Frame

Baseline to week 6 (endpoint)

Title

Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer

Description

Time Frame

Baseline to week 6 (endpoint)

Title

Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint

Description

Time Frame

Baseline to Week 6 (endpoint)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

Pfizer Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

77205

Country

United States

Facility Name

Pfizer Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

Pfizer Investigational Site

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

Country

United States

Facility Name

Pfizer Investigational Site

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

Pfizer Investigational Site

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027-5302

Country

United States

Facility Name

Pfizer Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92126

Country

United States

Facility Name

Pfizer Investigational Site

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

Pfizer Investigational Site

City

Darien

State/Province

Connecticut

ZIP/Postal Code

06820

Country

United States

Facility Name

Pfizer Investigational Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33432

Country

United States

Facility Name

Pfizer Investigational Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

Pfizer Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256-2006

Country

United States

Facility Name

Pfizer Investigational Site

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

Pfizer Investigational Site

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Pfizer Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Pfizer Investigational Site

City

Eagle

State/Province

Idaho

ZIP/Postal Code

83616

Country

United States

Facility Name

Pfizer Investigational Site

City

Granite City

State/Province

Illinois

ZIP/Postal Code

62040-4749

Country

United States

Facility Name

Pfizer Investigational Site

City

Terre Haute

State/Province

Indiana

ZIP/Postal Code

47802

Country

United States

Facility Name

Pfizer Investigational Site

City

Glen Burnie

State/Province

Maryland

ZIP/Postal Code

21061

Country

United States

Facility Name

Pfizer Investigational Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Pfizer Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63118

Country

United States

Facility Name

Pfizer Investigational Site

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Pfizer Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11223

Country

United States

Facility Name

Pfizer Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

Facility Name

Pfizer Investigational Site

City

Olean

State/Province

New York

ZIP/Postal Code

14760

Country

United States

Facility Name

Pfizer Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

Facility Name

Pfizer Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Pfizer Investigational Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19149

Country

United States

Facility Name

Pfizer Investigational Site

City

Scranton

State/Province

Pennsylvania

ZIP/Postal Code

18503

Country

United States

Facility Name

Pfizer Investigational Site

City

Lincoln

State/Province

Rhode Island

ZIP/Postal Code

02865

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77007

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903-4895

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23609405

Citation

Gao K, Pappadopulos E, Karayal ON, Kolluri S, Calabrese JR. Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia. J Clin Psychopharmacol. 2013 Jun;33(3):425-31. doi: 10.1097/JCP.0b013e3182917f3f.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281139&StudyName=A%20six-week%20flexible%20dose%20study%20evaluating%20the%20efficacy%20and%20safety%20of%20Geodon%20in%20patients%20with%20bipolar%20I%20depression.

Description

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Learn more about this trial

A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.

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A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.

Bipolar Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial