Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 4 study, sponsored by Northwell Health.
NCT01844700 is a Phase 4 study that was terminated before completion, run by Northwell Health. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT01844700 stopped before completion
NCT01844700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Ziprasidone is the first listed.
NCT01844700 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01844700's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia