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 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;
- Inventory for Depressive Symptoms - Clinicians form (IDS-C)
- Clinical Global Impression scale(CGI-BP)
- 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.
|Bipolar Disorder Depressive Disorder||Drug: buproprion (Wellbutrin) Drug: sertraline (Zoloft) Drug: venlafaxine (Effexor)||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Acute Efficacy of Bupropion, Sertraline, and Venlafaxine as Adjuvant Treatment to Mood Stabilizers in Bipolar Depression: A Randomized, Double-Blind, Comparative Study|
|Study Start Date:||June 1995|
|Estimated Study Completion Date:||May 2002|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001483
|United States, Maryland|
|National Institute of Mental Health (NIMH)|
|Bethesda, Maryland, United States, 20892|