Trial · NCT00141271

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

NCT00141271, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-03-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression. Trials, record NCT00141271. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00141271

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
NCT number: NCT00141271
Status: Completed
Phases: Phase 3
Enrollment: 536 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Bipolar Disorder
Interventions: Geodon (Ziprasidone), Geodon (Ziprasidone), Placebo
First posted: 2005-09-01
Last updated: 2021-03-25
Results first posted: 2009-03-24

Source ClinicalTrials.gov

Registered outcomes38

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	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	Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	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
Secondary	Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score	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.
Secondary	Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)	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
Secondary	Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12	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)
Secondary	Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7	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.
Secondary	Change in Hamilton Depression (HAM-D 17) Total Score	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.
Secondary	Change in Hamilton Anxiety Rating (HAM-A)	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.
Secondary	Change in Total Score of Young Mania Rating Scale (YMRS)	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.
Secondary	Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)	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

1 to 10 of 38Source ClinicalTrials.gov

See all 38 registered outcomes

Outcomes38

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	Baseline to 6 weeks	Intent to treat (ITT) population observed cases	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	Baseline to 6 weeks	Intent to treat (ITT) population observed cases.~Not all subjects answered at each Week	Participants	NUMBER
SECONDARY	Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score	Baseline to 6 weeks	Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each Week.	participants	NUMBER
SECONDARY	Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)	Baseline, 6 Weeks LOCF	Intent to treat (ITT) population observed cases, Last Observation Carried Forward (LOCF).	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12	Baseline to 6 weeks	ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6;~Not all subjects answered each week.	participants	NUMBER
SECONDARY	Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7	Baseline to 6 weeks	ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6~Not all subjects answered each week.	Participants	NUMBER
SECONDARY	Change in Hamilton Depression (HAM-D 17) Total Score	Baseline to 6 weeks	ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Hamilton Anxiety Rating (HAM-A)	Baseline to 6 weeks	ITT population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Total Score of Young Mania Rating Scale (YMRS)	Baseline to 6 weeks	ITT Population	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)	Baseline to 6 weeks	ITT population Observed Cases	score on scale	LEAST_SQUARES_MEAN

1 to 10 of 38Source ClinicalTrials.gov

See all 38 outcomes

Results by group375

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	120-160mg Ziprasidone	Week 1 (n=161, 153, 159)	-6.07	Standard Error 0.62	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	40-80 mg Ziprasidone	Week 1 (n=161, 153, 159)	-7.66	Standard Error 0.73	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	Placebo	Week 1 (n=161, 153, 159)	-5.75	Standard Error 0.65	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	120-160mg Ziprasidone	Week 2 (n=135, 142, 146)	-10.12	Standard Error 0.79	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	40-80 mg Ziprasidone	Week 2 (n=135, 142, 146)	-10.20	Standard Error 0.82	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	Placebo	Week 2 (n=135, 142, 146)	-9.47	Standard Error 0.77	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	120-160mg Ziprasidone	Week 3 (n=120, 131, 138)	-11.61	Standard Error 0.88	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	40-80 mg Ziprasidone	Week 3 (n=120, 131, 138)	-12.93	Standard Error 0.85	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	Placebo	Week 3 (n=120, 131, 138)	-11.37	Standard Error 0.81	score on scale
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score	120-160mg Ziprasidone	Week 4 (n=106, 126, 131)	-12.54	Standard Error 0.88	score on scale

1 to 10 of 375Source ClinicalTrials.gov

See all 375 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	120-160mg Ziprasidone	171
Overall Study	STARTED	40-80 mg Ziprasidone	165
Overall Study	STARTED	Placebo	168
Overall Study	COMPLETED	120-160mg Ziprasidone	91
Overall Study	COMPLETED	40-80 mg Ziprasidone	102
Overall Study	COMPLETED	Placebo	111
Overall Study	NOT COMPLETED	120-160mg Ziprasidone	80
Overall Study	NOT COMPLETED	40-80 mg Ziprasidone	63
Overall Study	NOT COMPLETED	Placebo	57

Source ClinicalTrials.gov

Adverse events81

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	120-160mg Ziprasidone	2	171
other	Diarrhoea	Gastrointestinal disorders	40-80 mg Ziprasidone	8	165
other	Diarrhoea	Gastrointestinal disorders	Placebo	14	168
other	Dry mouth	Gastrointestinal disorders	120-160mg Ziprasidone	13	171
other	Dry mouth	Gastrointestinal disorders	40-80 mg Ziprasidone	6	165
other	Dry mouth	Gastrointestinal disorders	Placebo	5	168
other	Nausea	Gastrointestinal disorders	120-160mg Ziprasidone	17	171
other	Nausea	Gastrointestinal disorders	40-80 mg Ziprasidone	10	165
other	Nausea	Gastrointestinal disorders	Placebo	11	168
other	Dizziness	Nervous system disorders	120-160mg Ziprasidone	12	171

1 to 10 of 81Source ClinicalTrials.gov

See all 81 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	120-160mg Ziprasidone
Total, all-cause mortality	40-80 mg Ziprasidone
Total, all-cause mortality	Placebo
Total, other adverse events	120-160mg Ziprasidone	89
Total, other adverse events	40-80 mg Ziprasidone	70
Total, other adverse events	Placebo	57
Total, serious adverse events	120-160mg Ziprasidone	7
Total, serious adverse events	40-80 mg Ziprasidone	3
Total, serious adverse events	Placebo	6

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23609405	DERIVED	PubMed
25012414	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Tower Planning	Secondary outcome	ConductCognition
Verbal Fluency	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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