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Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression

NCT00001483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2008-03-04

No results posted yet for this 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.

Conditions

Interventions

DRUG

buproprion (Wellbutrin)

DRUG

sertraline (Zoloft)

DRUG

venlafaxine (Effexor)

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-06-30
Completion
2002-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001483 on ClinicalTrials.gov