Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001483
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Acute Efficacy of Bupropion Sertraline and Venlafaxine as Adjuvant Treatment to Mood Stabilizers in Bipolar Depression A Randomized Double-Blind Comparative Study
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 scaleCGI-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 heshe 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
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 scaleCGI-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 heshe 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
Detailed Description:
This NIMH-Stanley Foundation Bipolar Network the Network study will be the first systematic assessment in bipolar depression of the comparative efficacy of bupropion Wellbutrin sertraline Zoloft and venlafaxine Effexor three newer antidepressants which have very different mechanisms of action Bupropion is largely dopaminergic while sertraline is a serotonin selective reuptake inhibitor SSRI and venlafaxine is a mixed serotonin norepinephrine and to a lesser extent dopamine reuptake inhibitor Subjects enrolled in this study will be bipolar patients on prophylactic treatment who experience a breakthrough major depressive episode Subjects will be assigned in a double-blind manner using a three-arm forced randomization procedure to antidepressant therapy with either bupropion sertraline or venlafaxine for a ten-week acute response trial The study medications will be assigned as adjuvant treatment to mood stabilizing medications which have proven unsatisfactorily effective within therapeutic ranges or at maximum tolerated doses All subjects will receive active drug at dosages established as clinically relevant for unipolar major depressive disorder Subjects and research personnel conducting cross-sectional and longitudinal rating assessments of mood and functioning will be blinded to treatment group assignment The primary outcome measures will be the Inventory for Depressive Symptoms - Clinician form IDS-C the Clinical Global Impression CGI-BP scale and the Life Charting Methodology LCM Subjects who worsen from baseline to week four of treatment will be considered non-responders to the initially assigned medication and will be offered re-randomization to either of the two drugs to which the subject was not originally randomized eg for bupropion non-response to either sertraline or venlafaxine for an additional ten-week acute response trial Responders to the acute trial enter a 12 month trial of continuation therapy to assess long term effects on prophylaxis of depression and possible induction of mania or cycle acceleration We also wish to explore possible clinical and biological correlates of acute and long term response to these antidepressants which have received almost no systematic study in bipolar illness One hypothesis of this study is that the acute efficacy for the three antidepressants would be the same Another hypothesis is that because of the potent noradrenergic NE effects venlafaxine would have a higher rate of inducing mania compared with bupropion or sertraline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-M-0129 | None | None | None |