Trial · NCT00490542
Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
NCT00490542, Phase 2, Completed, Tufts Medical Center; results first posted 2014-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State. Trials, record NCT00490542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00490542
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Ziprasidone (Geodon) for the Depressive Mixed State
- NCT number
- NCT00490542
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 73 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Bipolar Disorder, Bipolar Depression, Depression
- Interventions
- ziprasidone (Geodon), placebo
- First posted
- 2007-06-22
- Last updated
- 2016-07-29
- Results first posted
- 2014-01-08
- Limitations and caveats
One potential limitation in relation to secondary analyses would be sample size. The randomized study design should account for most potential confounding effects, but residual confounding cannot be completely eliminated without larger studies.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups. | Baseline to 6 weeks | Change in Montgomery-Asberg Depression Rating Scale score was compared between placebo and ziprasidone arms. The MADRS measures severity of depressive symptoms. The MADRS scale is from 0 (min) to 40 (max) with 0 being not depressed at all and 40 being the most severely depressed. 0 is the best outcome and 40 is the worst outcome. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups. | Baseline to 6 weeks | Power analysis, with beta=0.20 and two-tailed alpha=0.05, was based on pilot studies for the mania registration trials which included mixed episodes and assessed MADRS scores. A projected standard error of the mean difference was assumed to be about twice as much as the mean difference (5-15 points), producing a sample size of about 100. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups. | Ziprasidone Arm | 11.4 | 95% Confidence Interval 7.101815 to 15.69818 | Scores on a scale | |
| The Primary Outcome Measure Was Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores Over Weeks Between Groups. | Placebo Arm | 5.9 | 95% Confidence Interval 1.954045 to 9.845955 | Scores on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Double-blind Flexible-dose Placebo Arm | 38 | |
| Overall Study | STARTED | Double-blind Flexible-dose Ziprasidone Arm | 35 | |
| Overall Study | COMPLETED | Double-blind Flexible-dose Placebo Arm | 31 | |
| Overall Study | COMPLETED | Double-blind Flexible-dose Ziprasidone Arm | 31 | |
| Overall Study | NOT COMPLETED | Double-blind Flexible-dose Placebo Arm | 7 | |
| Overall Study | NOT COMPLETED | Double-blind Flexible-dose Ziprasidone Arm | 4 |
Source ClinicalTrials.gov
Adverse events8
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 | akathesia | Psychiatric disorders | Placebo Arm | 1 | 38 | 1 |
| other | akathesia | Psychiatric disorders | Geodon Arm | 1 | 35 | 1 |
| other | chest pain | General disorders | Placebo Arm | 1 | 38 | 1 |
| other | chest pain | General disorders | Geodon Arm | 0 | 35 | 0 |
| other | sedation | General disorders | Placebo Arm | 0 | 38 | 0 |
| other | sedation | General disorders | Geodon Arm | 2 | 35 | 2 |
| other | migraines | General disorders | Placebo Arm | 1 | 38 | 1 |
| other | migraines | General disorders | Geodon Arm | 0 | 35 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Arm | ||
| Total, all-cause mortality | Geodon Arm | ||
| Total, other adverse events | Placebo Arm | 3 | 38 |
| Total, other adverse events | Geodon Arm | 3 | 35 |
| Total, serious adverse events | Placebo Arm | 0 | 38 |
| Total, serious adverse events | Geodon Arm | 0 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22545088 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Geodon Arm vs Placebo Arm: serious adverse events |
Source 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.
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/NCT00490542
GET https://conductscience.org/api/trials/v1/NCT00490542/registered