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NCT00284791 · ClinicalTrials.gov registry record · NA
Lamotrigine in Treatment Resistant Depression in Adolescents
A NA study, sponsored by MaineHealth.
- Terminated
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT00284791: Clinical Trial NA study, sponsored by MaineHealth.
NCT00284791 is a NA study that was terminated before completion, run by MaineHealth. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00284791, a NA study, was terminated before completion, sponsored by MaineHealth.
- TERMINATED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The primary hypothesis of this study is that in fluoxetine (Prozac)-resistant adolescents with Major Depressive Disorder (MDD), Lamotrigine plus fluoxetine will be safe and as effective as sertraline (Zoloft). Our Primary Aim is to determine the efficacy and safety of Lamotrigine-augmentation of fluoxetine for treatment-resistant depression in adolescents. Our Secondary Aims are to characterize the factors associated with treatment-resistance for adolescents with major depression. Also to assess the relationships in the families of adolescents with major depression as they enter treatment, and to track the differences in family relationships for adolescents who respond or do not respond. We postulate that tense, frustrated, irritable, and over-involved relationships constitute a risk factor for attenuated improvement or relapse.
Interventions
- DRUG Lamotrigine (drug)
- DRUG Fluoxetine (drug)
- DRUG sertraline (drug)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-02 |
| Phase | NA |
Why NCT00284791 stopped before completion
NCT00284791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Lamotrigine (drug) is the first listed.
NCT00284791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00284791 about?
NCT00284791 is a clinical study titled "Lamotrigine in Treatment Resistant Depression in Adolescents". The primary hypothesis of this study is that in fluoxetine (Prozac)-resistant adolescents with Major Depressive Disorder (MDD), Lamotrigine plus fluoxetine will be safe and as effective as sertraline (Zoloft). Our Primary Aim is to determine the efficacy and safety of Lamotrigine-augmentation of fl...
What is the current status of trial NCT00284791?
This trial is currently terminated. It is a NA study. The enrollment target is 50 participants. The study started on 2006-01. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00284791?
The interventions under investigation include: Lamotrigine (drug) (DRUG), Fluoxetine (drug) (DRUG), sertraline (drug) (DRUG).
Who is sponsoring clinical trial NCT00284791?
This trial is sponsored by MaineHealth, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00284791's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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