Trial · NCT00312494
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
NCT00312494, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects. Trials, record NCT00312494. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00312494
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
- NCT number
- NCT00312494
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 680 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Bipolar Disorder
- Interventions
- Placebo, Ziprasidone, Ziprasidone
- First posted
- 2006-04-10
- Last updated
- 2021-03-29
- Results first posted
- 2010-01-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) | Baseline, Week 3 | YMRS is an 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. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value). |
| Secondary | Change From Baseline to Week 1 and Week 2 in YMRS | Baseline, Week 1, Week 2 | YMRS is an 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. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value). |
| Secondary | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores | Baseline, Week 1, Week 2, Week 3 | 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) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value). |
| Secondary | Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score | Baseline, Week 1, Week 2, Week 3 | 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. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value). |
| Secondary | Clinical Global Impression - Improvement (CGI-I) Scale Scores | Week 1, Week 2, Week 3 | 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 Positive and Negative Syndrome Scale (PANSS) Score | Baseline, Week 3 | PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value). |
| Secondary | Change From Baseline in Global Assessment of Functioning (GAF) Score | Baseline, Week 3 | GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value). |
| Secondary | Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score | Baseline, Week 3 | LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value). |
| Secondary | Anonymized Pharmacogenomic Blood Draw | Baseline | Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity. |
Source ClinicalTrials.gov
Outcomes9
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 3 in Young Mania Rating Scale (YMRS) | Baseline, Week 3 | Intent to Treat population (ITT): all randomized subjects who received at least 1 dose of double-blind medication, who had 1 baseline and at least 1 post-baseline primary efficacy evaluation; excluding data from 2 sites that were closed due to Good Clinical Practices (GCP) deviations. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 1 and Week 2 in YMRS | Baseline, Week 1, Week 2 | ITT population excluding data from 2 sites that were closed to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores | Baseline, Week 1, Week 2, Week 3 | ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score | Baseline, Week 1, Week 2, Week 3 | ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression - Improvement (CGI-I) Scale Scores | Week 1, Week 2, Week 3 | ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score | Baseline, Week 3 | ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Global Assessment of Functioning (GAF) Score | Baseline, Week 3 | ITT population excluding data from 2 sites that were closed due to GCP deviations. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score | Baseline, Week 3 | ITT population excluding data from 2 sites that were closed due to GCP deviations. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Anonymized Pharmacogenomic Blood Draw | Baseline | All subjects eligible (optional consent); samples were not to be analyzed as part of the current protocol and the analysis was not to be covered by the statistical analysis plan. |
Source ClinicalTrials.gov
Results by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) | Ziprasidone (Higher Dose) | -10.19 | Standard Error 0.78 | scores on scale | |
| Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) | Ziprasidone (Lower Dose) | -10.95 | Standard Error 0.80 | scores on scale | |
| Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) | Placebo | -9.47 | Standard Error 0.83 | scores on scale | |
| Change From Baseline to Week 1 and Week 2 in YMRS | Ziprasidone (Higher Dose) | Week 1 (n=202, 205, 200) | -4.38 | Standard Error 0.65 | scores on scale |
| Change From Baseline to Week 1 and Week 2 in YMRS | Ziprasidone (Lower Dose) | Week 1 (n=202, 205, 200) | -4.56 | Standard Error 0.65 | scores on scale |
| Change From Baseline to Week 1 and Week 2 in YMRS | Placebo | Week 1 (n=202, 205, 200) | -5.10 | Standard Error 0.70 | scores on scale |
| Change From Baseline to Week 1 and Week 2 in YMRS | Ziprasidone (Higher Dose) | Week 2 (n=178, 188, 186) | -7.10 | Standard Error 0.72 | scores on scale |
| Change From Baseline to Week 1 and Week 2 in YMRS | Ziprasidone (Lower Dose) | Week 2 (n=178, 188, 186) | -7.56 | Standard Error 0.73 | scores on scale |
| Change From Baseline to Week 1 and Week 2 in YMRS | Placebo | Week 2 (n=178, 188, 186) | -8.24 | Standard Error 0.76 | scores on scale |
| Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores | Ziprasidone (Higher Dose) | Week 1 (n=202, 205, 200) | -2.16 | Standard Error 0.52 | scores on scale |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ziprasidone (Higher Dose) | 232 | |
| Overall Study | STARTED | Ziprasidone (Lower Dose) | 226 | |
| Overall Study | STARTED | Placebo | 222 | |
| Overall Study | Received Study Treatment | Ziprasidone (Higher Dose) | 223 | |
| Overall Study | Received Study Treatment | Ziprasidone (Lower Dose) | 216 | |
| Overall Study | Received Study Treatment | Placebo | 217 | |
| Overall Study | COMPLETED | Ziprasidone (Higher Dose) | 161 | |
| Overall Study | COMPLETED | Ziprasidone (Lower Dose) | 168 | |
| Overall Study | COMPLETED | Placebo | 179 | |
| Overall Study | NOT COMPLETED | Ziprasidone (Higher Dose) | 71 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events117
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Ziprasidone (Higher Dose) | 6 | 223 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Ziprasidone (Lower Dose) | 2 | 216 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 2 | 217 | |
| other | Diarrhoea | Gastrointestinal disorders | Ziprasidone (Higher Dose) | 12 | 223 | |
| other | Diarrhoea | Gastrointestinal disorders | Ziprasidone (Lower Dose) | 10 | 216 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 217 | |
| other | Dry mouth | Gastrointestinal disorders | Ziprasidone (Higher Dose) | 6 | 223 | |
| other | Dry mouth | Gastrointestinal disorders | Ziprasidone (Lower Dose) | 1 | 216 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 3 | 217 | |
| other | Nausea | Gastrointestinal disorders | Ziprasidone (Higher Dose) | 11 | 223 |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ziprasidone (Higher Dose) | ||
| Total, all-cause mortality | Ziprasidone (Lower Dose) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ziprasidone (Higher Dose) | 134 | 223 |
| Total, other adverse events | Ziprasidone (Lower Dose) | 99 | 216 |
| Total, other adverse events | Placebo | 82 | 217 |
| Total, serious adverse events | Ziprasidone (Higher Dose) | 5 | 223 |
| Total, serious adverse events | Ziprasidone (Lower Dose) | 4 | 216 |
| Total, serious adverse events | Placebo | 4 | 217 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00312494
GET https://conductscience.org/api/trials/v1/NCT00312494/results?page=2