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NCT01844700 · ClinicalTrials.gov registry record · Phase 4
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain
A Phase 4 study, sponsored by Northwell Health.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01844700 is a Phase 4 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 14 participants.
The verdict
NCT01844700, a Phase 4 study, was terminated before completion, sponsored by Northwell Health.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
We will conduct a 12-week, randomized open label study, comparing usual care (UC) antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in children and adolescents aged 13-18 years old. Patients will have 10 days or less lifetime antipsychotic exposure and be in clinical need for antipsychotic treatment for a pediatric psychiatric disorder with FDA indication for antipsychotic use, i.e., bipolar mania, schizophrenia-spectrum disorders, and irritability associated with autistic disorder. In addition, we will also include youth fulfilling research diagnostic criteria for severe mood dysregulation (SMD). Randomization will be stratified by high vs. low genetic risk for antipsychotic-induced weight gain based on MC4R genotype and the primary outcome will be weight change from baseline to endpoint between ZIP and UC antipsychotic treatment in each of the two genotype groups. As detailed below, other metabolic and cardiac safety parameters will also be measured and compared across treatments in each of the genotype groups.
Interventions
- DRUG Ziprasidone
- DRUG aripiprazole, quetiapine, or risperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01844700
The ClinicalTrials.gov registry entry for NCT01844700 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ziprasidone is the first listed.
NCT01844700 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01844700 about?
NCT01844700 is a clinical study titled "1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain". We will conduct a 12-week, randomized open label study, comparing usual care (UC) antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in children and adolescents aged 13-18 years old. Patients will have 10 days or less lifetime antipsychotic exposure and be in clin...
What is the current status of trial NCT01844700?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2013-07. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01844700?
The interventions under investigation include: Ziprasidone (DRUG), aripiprazole, quetiapine, or risperidone (DRUG).
Who is sponsoring clinical trial NCT01844700?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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