Trial · NCT00483548

Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

NCT00483548, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-02-23

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ConductScience Library. Adjunctive Ziprasidone in the Treatment of Bipolar I Depression. Trials, record NCT00483548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00483548

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Trial

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

Title: Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
NCT number: NCT00483548
Status: Completed
Phases: Phase 3
Enrollment: 298 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Bipolar Disorder, Depression, Bipolar
Interventions: Ziprasidone, Placebo
First posted: 2007-06-07
Last updated: 2021-03-10
Results first posted: 2010-02-23

Source ClinicalTrials.gov

Registered outcomes17

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline, Week 6	MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.
Secondary	Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)	Baseline, Week 6	CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scored from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.
Secondary	MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6	Week 6	Number of subjects with MADRS total score ≤ 12 (indicates remission). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms).
Secondary	MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6	Week 6	Number of subjects with reduction of ≥50 percent (%) in MADRS total score (indicates response). MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Reduction calculated as (\[A-B\]/B\*100): A=value at observation; B=baseline value.
Secondary	Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6	Baseline, Week 6	Number of subjects with improvement defined as CGI-I response of 1 (very much improved) or 2 (much improved). CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected.
Secondary	Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5	MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal); total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as a difference between post-baseline observation and baseline MADRS score values.
Secondary	Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5	CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). Higher score = more affected. Change calculated as a difference between post-baseline observation and baseline CGI-S score values.
Secondary	CGI-Improvement Score	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). Higher score = more affected. Week 6 is the primary timepoint.
Secondary	Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score	Baseline, Week 2, Week 4, Week 6	HAM-A is a clinician rated 14-item scale that rates the intensity of psychic anxiety (items 1 to 6 and item 14) and somatic anxiety (items 7 to 13) on a 5-point severity scale; scores range from 0 (not present) to 4 (very severe); lower score indicates less affected. Change calculated as a difference between post-baseline observation and baseline HAM-A score values. Week 6 is the primary timepoint.
Secondary	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	YMRS is clinician rated 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \[rate and amount\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Higher scores indicate greater severity. Change calculated as a difference between post-baseline observation and baseline YMRS score values. Week 6 is the primary timepoint.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Baseline, Week 6	Intent to Treat analysis set (ITT): all randomized subjects who received at least 1 dose of double-blind treatment and had at least 1 post-baseline primary efficacy evaluation.	scores on scale	MEAN
SECONDARY	Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)	Baseline, Week 6	ITT	scores on scale	MEAN
SECONDARY	MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6	Week 6	ITT; Last observation carried forward (LOCF)	participants	NUMBER
SECONDARY	MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6	Week 6	ITT; LOCF	participants	NUMBER
SECONDARY	Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6	Baseline, Week 6	ITT; LOCF	participants	NUMBER
SECONDARY	Change From Baseline in MADRS Total Score (Post-baseline Excluding Week 6)	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5	ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.	scores on scale	MEAN
SECONDARY	Change From Baseline in CGI-Severity Score (Post-baseline Excluding Week 6)	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5	ITT; LOCF; (n)=number of subjects with analyzable data: baseline and post-baseline observation for ziprasidone, placebo, respectively.	scores on scale	MEAN
SECONDARY	CGI-Improvement Score	Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.	scores on scale	MEAN
SECONDARY	Change From Baseline in Hamilton Anxiety Scale (HAM-A) Total Score	Baseline, Week 2, Week 4, Week 6	ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.	scores on scale	MEAN
SECONDARY	Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6	ITT; LOCF; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively.	scores on scale	MEAN

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group130

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

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Ziprasidone	-14.7	Standard Deviation 10.7	scores on scale
Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	Placebo	-13.2	Standard Deviation 10.4	scores on scale
Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)	Ziprasidone	-1.5	Standard Deviation 1.3	scores on scale
Change From Baseline to Week 6 in Clinical Global Impression - Severity Scale (CGI-Severity or CGI-S)	Placebo	-1.5	Standard Deviation 1.2	scores on scale
MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6	Ziprasidone	48		participants
MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6	Placebo	54		participants
MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6	Ziprasidone	62		participants
MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6	Placebo	65		participants
Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6	Ziprasidone	66		participants
Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6	Placebo	69		participants

1 to 10 of 130Source ClinicalTrials.gov

See all 130 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ziprasidone	148
Overall Study	STARTED	Placebo	150
Overall Study	Received Study Treatment	Ziprasidone	147
Overall Study	Received Study Treatment	Placebo	147
Overall Study	COMPLETED	Ziprasidone	88
Overall Study	COMPLETED	Placebo	104
Overall Study	NOT COMPLETED	Ziprasidone	60
Overall Study	NOT COMPLETED	Placebo	46

Source ClinicalTrials.gov

Adverse events38

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	Ziprasidone	7	147
other	Diarrhoea	Gastrointestinal disorders	Placebo	11	147
other	Nausea	Gastrointestinal disorders	Ziprasidone	16	147
other	Nausea	Gastrointestinal disorders	Placebo	8	147
other	Fatigue	General disorders	Ziprasidone	19	147
other	Fatigue	General disorders	Placebo	6	147
other	Akathisia	Nervous system disorders	Ziprasidone	8	147
other	Akathisia	Nervous system disorders	Placebo	2	147
other	Dizziness	Nervous system disorders	Ziprasidone	19	147
other	Dizziness	Nervous system disorders	Placebo	9	147

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ziprasidone
Total, all-cause mortality	Placebo
Total, other adverse events	Ziprasidone	96	147
Total, other adverse events	Placebo	57	147
Total, serious adverse events	Ziprasidone	1	147
Total, serious adverse events	Placebo	6	147

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21672493	DERIVED

Source 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 comparisons4

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

Comparison	Source
Ziprasidone vs Placebo: MADRS Response: Number of Subjects With Total MADRS Score Reduction ≥ 50 Percent From Baseline at Week 6	Trial comparisons
Ziprasidone vs Placebo: Clinical Global Impression - Improvement Scale (CGI-Improvement or CGI-I): Number of Subjects With Response (Much Improved or Very Much Improved) at Week 6	Trial comparisons
Ziprasidone vs Placebo: MADRS Remission: Number of Subjects With Total MADRS Score ≤ 12 at Week 6	Trial comparisons
Ziprasidone vs Placebo: serious adverse events	Trial comparisons

Tests0

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

None in this release.

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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