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NCT00001483 · ClinicalTrials.gov registry record · Phase 2
Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT00001483: Completed Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT00001483 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001483, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake inhibitor. Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are presently taking medication to prevent the symptoms of the disease (prophylactic treatment), but have had breakthrough episodes of depression despite taking their medication. Patients will receive any one of the three antidepressant medications as noted above plus a placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in addition to their regular medication for bipolar disorder. All of the doses will be calculated as effective for the treatment of a unipolar major depressive disorder. The patient will continue receiving the medication for ten weeks. The effectiveness of the drug treatment will be measured by using three different scales; 1. Inventory for Depressive Symptoms - Clinicians form (IDS-C) 2. Clinical Global Impression scale(CGI-BP) 3. Life Charting Methodology (LCM) Patients who do not respond to their medication within ten weeks from the beginning of the study will be considered as non-responders and be offered the opportunity to start the study again, taking one of the two remaining medications. For example, if a patient was assigned to take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either Zoloft or Effexor. Patients that do respond in the first ten weeks of the study will be eligible to continue taking the medication for one year to assess the long term effectiveness of the drug on preventing episodes of depression and to assess for any possible differential induction of mania.
Interventions
- DRUG venlafaxine (Effexor)
- DRUG sertraline (Zoloft)
- DRUG buproprion (Wellbutrin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 1995-06 |
| Est. Completion | 2002-05 |
| Phase | Phase 2 |
What the finished NCT00001483 record still lists
NCT00001483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 3 interventions - of which venlafaxine (Effexor) is the first listed.
NCT00001483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001483 about?
NCT00001483 is a clinical study titled "Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression". This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works ...
What is the current status of trial NCT00001483?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 1995-06. Estimated completion is 2002-05.
What interventions are being tested in trial NCT00001483?
The interventions under investigation include: venlafaxine (Effexor) (DRUG), sertraline (Zoloft) (DRUG), buproprion (Wellbutrin) (DRUG).
Who is sponsoring clinical trial NCT00001483?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001483's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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