A Phase 4 interventional study of ziprasidone and Sugar pill in Depression and Bipolar Disorder, sponsored by Tufts Medical Center. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-24.
Sponsored by Tufts Medical Center · Phase 4, Interventional, and Treatment
The primary outcome of this study is to determine if predictors of response can select a population of patients with MDD that is effectively treatable by augmentation with ziprasidone.
Major depressive disorder (MDD) is a broad category, including many forms of depressive illness, including those with only a single major depressive episode, those with episodic recurrence with intervening well states, those with chronic depressive/anxious states without intervening euthymia, and those with manic symptoms that do not meet threshold definitions of full mania/hypomania.
In this heterogenous, large diagnostic definition, important groups of patients do not appear to respond well to antidepressants, and, conversely, based on observational studies, may respond well to neuroleptics. These predictors of response have begun to be identified and may serve to better design studies of neuroleptics in depressive illnesses.
Among these predictors of response in MDD are clinical features that are more similar to bipolar illness than unipolar depression. These include a family history of bipolar disorder, antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical depression, early age of onset of depression (\< age 20), failure to respond to antidepressants, and antidepressant tolerance (initial response followed by later loss of response).
The investigators propose to use these predictors to pick out patients that are more likely to respond to Geodon for MDD. This will be the first RCT of these predictors of depressive response applied to neuroleptics.
This will be a three-site, block randomized (1:1 ratio) double-blind, placebo-controlled prospective cross-over study with 50 subjects. Patients will be randomized to receiving ziprasidone-washout-placebo or placebo- washout-ziprasidone for 13-weeks.
Primary and Secondary and safety outcomes: The primary outcome measure will be change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) score to end of treatment. Safety outcomes will be determined by spontaneously reported adverse events on the case report form.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 49 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
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Exclusion Criteria:
Patients are randomized to a sugar pill (placebo), added to their current medications.
Drug: Sugar pill
Patients are randomized to ziprasidone, added to their current medications.
Drug: ziprasidone
Ziprasidone will be administered as a pill. The once-daily total daily dose will be 80-160 mg/d of ziprasidone. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly.
Also known as: Geodon
The once-daily total daily dose will be 80-160 mg/d of the sugar pill. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly.
Also known as: Placebo
MADRS Improvement Over 6 Weeks
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.
Time frame: 13 weeks (Two 6 week periods plus a one week washout)
Predictors of Bipolarity to Define the Study Population
The specific bipolarity predictors in patients with MDD were assessed.
Time frame: 13 weeks
| Milestone | Placebo-washout-ziprasidone | Ziprasidone-washout-placebo |
|---|---|---|
| Started | 25 | 24 |
| Completed | 25 | 24 |
| Not completed | 0 | 0 |
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.
| units on a scale | Placebo | Ziprasidone |
|---|---|---|
| MADRS Improvement Over 6 Weeks | 10.0 ± 10.3 | 6.7 ± 8.2 |
The specific bipolarity predictors in patients with MDD were assessed.
| percentage of subjects | All Study Participants |
|---|---|
| Antidepressant tolerance | 75.0 |
| Antidepressant nonresponse | 73.5 |
| Highly recurrent depressive episodes | 72.3 |
| Atypical depression | 52.9 |
| Family history of bipolar disorder | 46.0 |
| Early age of onset | 47.6 |
| Antidepressant-induced mania | 8.8 |
Collected over 13 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/49 (0%) | 0/49 (0%) |
| Ziprasidone | — | 1/49 (2%) | 21/49 (42.9%) |
| Event | Placebo | Ziprasidone |
|---|---|---|
| seizureNervous system disorders | 0/49 | 1/49 |
| Event | Placebo | Ziprasidone |
|---|---|---|
| sedationNervous system disorders | 0/49 | 8/49 |
| constipationGastrointestinal disorders | 0/49 | 5/49 |
| nauseaGastrointestinal disorders | 0/49 | 4/49 |
| dry mouthNervous system disorders | 0/49 | 4/49 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 42.6 ± 11.4 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 33 |
| Male | 16 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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