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NCT01464229 · ClinicalTrials.gov registry record · Phase 4
Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability
A Phase 4 study, sponsored by Maurizio Fava, MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01464229: Completed Phase 4 study, sponsored by Maurizio Fava, MD.
NCT01464229 is a Phase 4 study that has completed, run by Maurizio Fava, MD. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01464229, a Phase 4 study, has completed, sponsored by Maurizio Fava, MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological features seem to be very promising in treating symptoms like anger and anxiety (Fava et al., 1997; Wang et al., 2010). The investigators therefore feel that an adequately sized, well powered, double-blind, placebo-controlled, randomized, cross-over study of iloperidone augmentation of SSRIs among MDD outpatients in partial remission with residual anger and irritability is warranted at this point to evaluate its efficacy, safety and tolerability on residual anger, irritability and depressive symptoms. Main hypothesis: Adults with MDD in partial remission, who are experiencing residual symptoms of anger and irritability, assigned to treatment with iloperidone will demonstrate a significantly greater reduction in the total score of the Anger/Hostility Scale of the Symptom Questionnaire from baseline to endpoint than those assigned to placebo using the cross-over design.
Primary Outcome
Of the 20 patients randomized, data was analyzed for 13 completers. Symptom Questionnaire (SQ) Anger/Hostility Scale; this is a 23-item subscale of the 92-item Symptom Questionnaire. This score ranges from 0 to 23; higher values represent higher anger and hostility.
Interventions
- DRUG Placebo
- DRUG Iloperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01464229 record still lists
NCT01464229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01464229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01464229 about?
NCT01464229 is a clinical study titled "Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability". Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological features seem to be very promising in treating symptoms like anger and anxiety (Fava et al., 1997; Wang et al., 2010). T...
What is the current status of trial NCT01464229?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2012-04. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01464229?
The interventions under investigation include: Placebo (DRUG), Iloperidone (DRUG).
Who is sponsoring clinical trial NCT01464229?
This trial is sponsored by Maurizio Fava, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01464229's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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