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NCT01179009 · ClinicalTrials.gov registry record · NA
Treatment Resistant Depression (Pilot)
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01179009 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 20 participants.
The verdict
NCT01179009, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Treatment resistant depression (TRD) is a major public health problem. Current therapeutic options for this patient population remain limited. With all available treatments, only a sub-set of those patients who achieve an antidepressant response are likely to achieve treatment-induced remission. The need for antidepressant medication that can provide both rapid and long lasting relief of TRD symptoms is widely recognized. There is new evidence that drugs that block NMDA glutamate receptors (NMDA antagonists) are promising candidates for meeting this need. Existing studies in TRD have used only a low-dose, brief infusion of ketamine that would not be expected to re-sensitize the NMDA receptor; in agreement with this theory, these prior studies have found only temporary improvements of depression. Our key hypothesis is that a higher-dose, longer-term ketamine infusion, such as that used in chronic pain studies, would provide a more robust and lasting improvement from depression. Accordingly, we will test whether a 100-hour ketamine infusion would be more effective than the standard 40-minute ketamine infusion currently used in other TRD studies. We will randomize subjects to one of 2 arms: (1) 100-hour (+/- 4 hours) ketamine infusion plus clonidine for the entire infusion (2) 40-minute ketamine infusion (plus clonidine) following a 100+/- hour saline infusion. All subjects will receive clonidine, an alpha-2 agonist, to minimize side effects of ketamine (namely, brief/mild psychotic and cognitive symptoms).
Interventions
- DRUG placebo
- DRUG Ketamine
- DRUG Clonidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-06-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01179009
The ClinicalTrials.gov registry entry for NCT01179009 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01179009 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01179009 about?
NCT01179009 is a clinical study titled "Treatment Resistant Depression (Pilot)". Treatment resistant depression (TRD) is a major public health problem. Current therapeutic options for this patient population remain limited. With all available treatments, only a sub-set of those patients who achieve an antidepressant response are likely to achieve treatment-induced remission. The...
What is the current status of trial NCT01179009?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2012-04. Estimated completion is 2015-06-05.
What interventions are being tested in trial NCT01179009?
The interventions under investigation include: placebo (DRUG), Ketamine (DRUG), Clonidine (DRUG).
Who is sponsoring clinical trial NCT01179009?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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