Trial · NCT01168674
Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder
NCT01168674, Phase 4, Completed, Tufts Medical Center; results first posted 2017-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder. Trials, record NCT01168674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01168674
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Predictors of Response to Augmentation With Ziprasidone (Geodon®) in Major Depressive Disorder
- NCT number
- NCT01168674
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 49 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Depression, Bipolar Disorder
- Interventions
- ziprasidone, Sugar pill
- First posted
- 2010-07-23
- Last updated
- 2017-02-24
- Results first posted
- 2017-02-13
- Limitations and caveats
All crossover studies have the limitation of order effects: the order in which treatments were given could impact the results. The definition of bipolarity predictors also may not have effectively identified groups correctly.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MADRS Improvement Over 6 Weeks | 13 weeks (Two 6 week periods plus a one week washout) | Montgomery Asberg Depression scale improvement was assessed in two 6 week crossover periods. Minimum score on MADRS is 0, the maximum is 60. Higher scores represent a worse outcome, i.e., greater severity of depressive symptoms. Scores of about 20 and above are generally seen as consistent with being in a full major depressive episode. No subscales were used or combined. |
| Secondary | Predictors of Bipolarity to Define the Study Population | 13 weeks | The specific bipolarity predictors in patients with MDD were assessed. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MADRS Improvement Over 6 Weeks | 13 weeks (Two 6 week periods plus a one week washout) | units on a scale | MEAN | |
| SECONDARY | Predictors of Bipolarity to Define the Study Population | 13 weeks | The most common predictor was antidepressant tolerance, as reported below in 37 subjects. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MADRS Improvement Over 6 Weeks | Placebo | 10.0 | Standard Deviation 10.3 | units on a scale | |
| MADRS Improvement Over 6 Weeks | Ziprasidone | 6.7 | Standard Deviation 8.2 | units on a scale | |
| Predictors of Bipolarity to Define the Study Population | All Study Participants | Antidepressant tolerance | 75.0 | percentage of subjects | |
| Predictors of Bipolarity to Define the Study Population | All Study Participants | Antidepressant nonresponse | 73.5 | percentage of subjects | |
| Predictors of Bipolarity to Define the Study Population | All Study Participants | Highly recurrent depressive episodes | 72.3 | percentage of subjects | |
| Predictors of Bipolarity to Define the Study Population | All Study Participants | Atypical depression | 52.9 | percentage of subjects | |
| Predictors of Bipolarity to Define the Study Population | All Study Participants | Family history of bipolar disorder | 46.0 | percentage of subjects | |
| Predictors of Bipolarity to Define the Study Population | All Study Participants | Early age of onset | 47.6 | percentage of subjects | |
| Predictors of Bipolarity to Define the Study Population | All Study Participants | Antidepressant-induced mania | 8.8 | percentage of subjects |
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 | Placebo-washout-ziprasidone | 25 | |
| Overall Study | STARTED | Ziprasidone-washout-placebo | 24 | |
| Overall Study | COMPLETED | Placebo-washout-ziprasidone | 25 | |
| Overall Study | COMPLETED | Ziprasidone-washout-placebo | 24 | |
| Overall Study | NOT COMPLETED | Placebo-washout-ziprasidone | 0 | |
| Overall Study | NOT COMPLETED | Ziprasidone-washout-placebo | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | sedation | Nervous system disorders | Placebo | 0 | 49 | 0 |
| other | sedation | Nervous system disorders | Ziprasidone | 8 | 49 | 8 |
| other | nausea | Gastrointestinal disorders | Placebo | 0 | 49 | 0 |
| other | nausea | Gastrointestinal disorders | Ziprasidone | 4 | 49 | 4 |
| other | dry mouth | Nervous system disorders | Placebo | 0 | 49 | 0 |
| other | dry mouth | Nervous system disorders | Ziprasidone | 4 | 49 | 4 |
| other | constipation | Gastrointestinal disorders | Placebo | 0 | 49 | 0 |
| other | constipation | Gastrointestinal disorders | Ziprasidone | 5 | 49 | 5 |
| serious | seizure | Nervous system disorders | Placebo | 0 | 49 | 0 |
| serious | seizure | Nervous system disorders | Ziprasidone | 1 | 49 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Ziprasidone | ||
| Total, other adverse events | Placebo | 0 | 49 |
| Total, other adverse events | Ziprasidone | 21 | 49 |
| Total, serious adverse events | Placebo | 0 | 49 |
| Total, serious adverse events | Ziprasidone | 1 | 49 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Ziprasidone vs Placebo: 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/NCT01168674
GET https://conductscience.org/api/trials/v1/NCT01168674/registered