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NCT01714310 · ClinicalTrials.gov registry record · Phase 2
Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation
A Phase 2 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT01714310 is a Phase 2 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 34 participants.
The verdict
NCT01714310, a Phase 2 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
This project will characterize children and adolescents with severe mood dysregulation (SMD) and conduct a pilot study of combination pharmacotherapy as a basis for future intervention trials. Eligible participants assessed for SMD will have 4 weeks open titration with lisdexamfetamine (LDX) to optimal dose, followed by double-blind randomization to fluoxetine (N=25) or placebo (N=25) in combination with optimized LDX for an additional 8 weeks. Participants will be monitored for clinical response and adverse events. Specific aims are: #1: To define youth meeting SMD criteria in terms of psychiatric comorbidity, neurocognitive functioning, and a potential "bio-signature" derived from electroencephalography (EEG). Specific hypotheses to be tested include: 1) that SMD participants will differ in comparison to non-SMD individuals in our pre-existing database on patterns of a) psychiatric comorbidity, b) symptoms, c) behavioral ratings, and d) neurocognitive functioning, and 2) that a distinct EEG bio-signature will be confirmed in individuals formally diagnosed with SMD. #2: To conduct a preliminary study of sequential pharmacotherapy for SMD with a stimulant followed by randomized, placebo-controlled selective serotonin re-uptake inhibitor (SSRI) therapy to evaluate the feasibility of recruitment and enrollment and assess the suitability of the proposed combination treatment as a basis for future clinical investigations. Specific hypotheses to be tested include: 1) that significant improvement in Clinical Global Impression - Improvement -SMD (CGI-I-SMD) scores and other secondary measures are evident after open-label LDX titration; 2) that participants randomized to fluoxetine will demonstrate additional significant improvement in CGI-I-SMD scores and other secondary measures in comparison to participants randomized to placebo; 3) that combination LDX and SSRI therapy is safe and well tolerated, and 4) that EEG profiles will normalize with treatment.
Interventions
- DRUG Placebo
- DRUG fluoxetine
- DRUG lisdexamfetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01714310
The ClinicalTrials.gov registry entry for NCT01714310 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01714310 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01714310 about?
NCT01714310 is a clinical study titled "Characterization and Sequential Pharmacotherapy of Severe Mood Dysregulation". This project will characterize children and adolescents with severe mood dysregulation (SMD) and conduct a pilot study of combination pharmacotherapy as a basis for future intervention trials. Eligible participants assessed for SMD will have 4 weeks open titration with lisdexamfetamine (LDX) to opt...
What is the current status of trial NCT01714310?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2013-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01714310?
The interventions under investigation include: Placebo (DRUG), fluoxetine (DRUG), lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT01714310?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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