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

Primary Purpose

Bipolar Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Geodon (Ziprasidone)

Placebo

About this trial

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

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 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

20-40mg BID arm

60-80mg bid arm

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

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

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 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.

Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (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

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

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)

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

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.

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

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.

Change in Hamilton Anxiety Rating (HAM-A)

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.

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

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.

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

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

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

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

Change in Total Score in Hamilton Depression (HAM-D 25)

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.

Response as Measured by CGI-I Score Less Than or Equal to 2

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

Change in Sheehan Disability Scale (SDS) Total Score at Endpoint

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.

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

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

Change in Bech Melancholia Score

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.

Change in Anxiety/Somatizations Factor Total Score

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.

Change in Retardation Factor Scores

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.

Change in Sleep Disturbance Factor Score

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.

Change in Verbal Memory Trial Performance Total Score at Endpoint

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.

Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint

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.

Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint

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.

Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint

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

Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint

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

Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint

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

Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint

Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint

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

Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint

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

Change in Digit Sequencing Task at Endpoint

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.

Change in Token Motor Task at Endpoint

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

Change in Verbal Fluency in Naming Categories at Endpoint

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.

Change in Verbal Fluency Controlled Word Association at Endpoint

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

Change in Symbol Coding at Endpoint

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.

Change in Tower of London Test at Endpoint

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.

Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint

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.

Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint

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

Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint

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

Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint

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

Full Information

NCT ID

NCT00141271

First Posted

August 30, 2005

Last Updated

March 2, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00141271

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 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 Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

536 (Actual)

8. Arms, Groups, and Interventions

Arm Title

20-40mg BID arm

Arm Type

Active Comparator

Arm Title

60-80mg bid arm

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Geodon (Ziprasidone)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Geodon (Ziprasidone)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to 6 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to 6 weeks

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 6 weeks

Title

Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, 6 Weeks LOCF

Title

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

Description

Time Frame

Baseline to 6 weeks

Title

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

Description

Time Frame

Baseline to 6 weeks

Title

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

Description

Time Frame

Baseline to 6 weeks

Title

Change in Hamilton Anxiety Rating (HAM-A)

Description

Time Frame

Baseline to 6 weeks

Title

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

Description

Time Frame

Baseline to 6 weeks

Title

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

Description

Time Frame

Baseline to 6 weeks

Title

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

Description

Time Frame

Baseline to 6 weeks

Title

Change in Total Score in Hamilton Depression (HAM-D 25)

Description

Time Frame

Baseline to 6 Weeks

Title

Response as Measured by CGI-I Score Less Than or Equal to 2

Description

Time Frame

Week 1 through Week 6 (endpoint)

Title

Change in Sheehan Disability Scale (SDS) Total Score at Endpoint

Description

Time Frame

Baseline to Week 6

Title

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

Description

Time Frame

Baseline to 6 Weeks

Title

Change in Bech Melancholia Score

Description

Time Frame

Baseline to 6 Weeks

Title

Change in Anxiety/Somatizations Factor Total Score

Description

Time Frame

Baseline to 6 Weeks

Title

Change in Retardation Factor Scores

Description

Time Frame

Baseline to 6 Weeks

Title

Change in Sleep Disturbance Factor Score

Description

Time Frame

Baseline to 6 weeks

Title

Change in Verbal Memory Trial Performance Total Score at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint

Description

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

Time Frame

Baseline to Week 6 LOCF

Title

Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint

Description

Time Frame

Baseline to Week 6 LOCF

Title

Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint

Description

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

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint

Description

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

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Digit Sequencing Task at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Token Motor Task at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Verbal Fluency in Naming Categories at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Verbal Fluency Controlled Word Association at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Symbol Coding at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Tower of London Test at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint

Description

Time Frame

Baseline to 6 Weeks LOCF

Title

Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint

Description

Time Frame

Baseline to Week 6 LOCF

Title

Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint

Description

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

Time Frame

Baseline to Week 6 LOCF

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Pfizer Investigational Site

City

Dana Point

State/Province

California

ZIP/Postal Code

92629

Country

United States

Facility Name

Pfizer Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Pfizer Investigational Site

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Pfizer Investigational Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Pfizer Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Pfizer Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

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

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Pfizer Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Pfizer Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Pfizer Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Pfizer Investigational Site

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Facility Name

Pfizer Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Pfizer Investigational Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Pfizer Investigational Site

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Pfizer Investigational Site

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Facility Name

Pfizer Investigational Site

City

Schaumburg

State/Province

Illinois

ZIP/Postal Code

60194

Country

United States

Facility Name

Pfizer Investigational Site

City

Greenwood

State/Province

Indiana

ZIP/Postal Code

46143

Country

United States

Facility Name

Pfizer Investigational Site

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47905

Country

United States

Facility Name

Pfizer Investigational Site

City

Prarie Village

State/Province

Kansas

ZIP/Postal Code

66206

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70114

Country

United States

Facility Name

Pfizer Investigational Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Pfizer Investigational Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Pfizer Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Pfizer Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Facility Name

Pfizer Investigational Site

City

Flowood

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63144

Country

United States

Facility Name

Pfizer Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

Pfizer Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

Pfizer Investigational Site

City

Clementon

State/Province

New Jersey

ZIP/Postal Code

08021

Country

United States

Facility Name

Pfizer Investigational Site

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Pfizer Investigational Site

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

Pfizer Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0001

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44113

Country

United States

Facility Name

Pfizer Investigational Site

City

Mayfield

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73118

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19131

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

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Pfizer Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

Pfizer Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Pfizer Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203-1515

Country

United States

Facility Name

Pfizer Investigational Site

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Pfizer Investigational Site

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

Pfizer Investigational Site

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0188

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77555

Country

United States

Facility Name

Pfizer Investigational Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75062

Country

United States

Facility Name

Pfizer Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Pfizer Investigational Site

City

Richardson

State/Province

Texas

ZIP/Postal Code

75080

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

San Antonio

State/Province

Texas

ZIP/Postal Code

78284-7792

Country

United States

Facility Name

Pfizer Investigational Site

City

Wichita Falls

State/Province

Texas

ZIP/Postal Code

76309

Country

United States

Facility Name

Pfizer Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22201

Country

United States

Facility Name

Pfizer Investigational Site

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22041

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23229

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Pfizer Investigational Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23452

Country

United States

Facility Name

Pfizer Investigational Site

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98033

Country

United States

Facility Name

Pfizer Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Pfizer Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53227

Country

United States

Facility Name

Pfizer Investigational Site

City

West Allis

State/Province

Wisconsin

ZIP/Postal Code

53227

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25012414

Citation

Keefe RS, Fox KH, Davis VG, Kennel C, Walker TM, Burdick KE, Harvey PD. The Brief Assessment of Cognition In Affective Disorders (BAC-A):performance of patients with bipolar depression and healthy controls. J Affect Disord. 2014 Sep;166:86-92. doi: 10.1016/j.jad.2014.05.002. Epub 2014 May 11.

Results Reference

derived

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=A1281136&StudyName=A%20Six-Week%20Study%20Evaluating%20The%20Efficacy%20And%20Safety%20Of%20Geodon%20In%20Patients%20With%20A%20Diagnosis%20Of%20Bipolar%20I%20Depression

Description

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Learn more about this trial

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

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

Bipolar Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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