Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086307
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2004-06-29
Brief Title:
Lexapro and Pramipexole and to Treat Major Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Combining a Dopamine Agonist and Selective Serotonin Reuptake Inhibitor for Treatment of Depression A Double-Blind Randomized Study
Status:
COMPLETED
Status Verified Date:
2013-01
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 compares the effectiveness of the combination of antidepressants Lexapro and Pramipexole with the effectiveness of each antidepressant alone
Purpose Patients between 18 and 65 years of age with Major Depressive Disorder without psychotic features may be eligible for this 9-week study Candidates must currently be in a major depressive episode of at least 4 weeks duration have failed to respond to treatment with an SSRI Prozac Zoloft Paxil Luvox Celexa and not have failed to respond to more than four antidepressants for the current episode Candidates are screened with a physical examination psychiatric evaluation blood tests review of vital signs height and weight measurements electrocardiogram ECG urine test for illegal drugs and pregnancy test for women
Participants are tapered off antidepressants or other medications prohibited during the study and remain drug-free for 1 week before starting treatment They are then randomly assigned to take pramipexole and escitalopram pramipexole alone or escitalopram alone for 6 weeks During the study participants come to the clinic eight times for health assessments and symptoms assessments which include a check of vital signs and rating scales for depression and anxiety adverse events and sexual functioning Blood and urine samples are collected periodically to monitor health detect pregnancy in women and detect illicit drug use
At the end of the 6-week treatment period participants have a physical examination ECG blood test and check of vital signs Short-term anti-depressant treatment is offered and plans are made for long-term treatment
Atendemos pacientes de habla hispana
Purpose Patients between 18 and 65 years of age with Major Depressive Disorder without psychotic features may be eligible for this 9-week study Candidates must currently be in a major depressive episode of at least 4 weeks duration have failed to respond to treatment with an SSRI Prozac Zoloft Paxil Luvox Celexa and not have failed to respond to more than four antidepressants for the current episode Candidates are screened with a physical examination psychiatric evaluation blood tests review of vital signs height and weight measurements electrocardiogram ECG urine test for illegal drugs and pregnancy test for women
Participants are tapered off antidepressants or other medications prohibited during the study and remain drug-free for 1 week before starting treatment They are then randomly assigned to take pramipexole and escitalopram pramipexole alone or escitalopram alone for 6 weeks During the study participants come to the clinic eight times for health assessments and symptoms assessments which include a check of vital signs and rating scales for depression and anxiety adverse events and sexual functioning Blood and urine samples are collected periodically to monitor health detect pregnancy in women and detect illicit drug use
At the end of the 6-week treatment period participants have a physical examination ECG blood test and check of vital signs Short-term anti-depressant treatment is offered and plans are made for long-term treatment
Atendemos pacientes de habla hispana
Detailed Description:
Despite the availability of a wide range of antidepressant drugs 30 to 40 of patients with major depression fail to respond to first-line antidepressant eg selective serotonin reuptake inhibitors SSRIs treatment despite adequate dosage duration and compliance Furthermore these medications may take weeks to months to achieve their full effects and in the meantime patients continue to suffer from their symptoms and continue to be at risk of self-harm as well as harm to their personal and professional lives Thus there is a clear need to develop novel and improved therapeutics for treatment-resistant major depression that are more effective and have a rapid onset of action Preclinical and clinical studies suggest that antidepressants with a combined mechanism of action eg combination of a selective serotonin-reuptake inhibitor SSRI and a norepinephrine reuptake inhibitor may be more effective than either agent alone in achieving remission Nelson et al 2004 Thus it stands to reason that other combinations of antidepressants with other mechanisms of action when combined may have a synergistic effect that is superior to an antidepressant with a single mechanism of action Preclinical and clinical studies suggest that the dopaminergic system may play a major role in the pathophysiology of depression Preclinical studies suggest synergistic antidepressant effects with the combination of a SSRI and a selective D3 receptor agonist in animal models of depression Similarly preliminary clinical studies suggest synergism with combination treatment that affects the serotonin and dopamine systems Together these data suggests that treatments which affect the serotonin and dopamine systems will be more effective than agents which use a single mechanism We propose to compare the combination of a selective dopaminergic agonist and a SSRI in patients with treatment-resistant major depression To our knowledge this will be the only controlled double-blind study to date that will examine the efficacy of a serotonin and dopamine combination given from the start of treatment
Patients ages 18 years or older with a diagnosis of major depression without psychotic features will be randomized to the combination of a selective dopaminergic receptor agonist and a SSRI or either drug alone for a period of 6 weeks Acute efficacy will be determined by demonstrating a greater remission rate using specified criteria Approximately 115 patients with acute major depression will be enrolled in the study
Patients ages 18 years or older with a diagnosis of major depression without psychotic features will be randomized to the combination of a selective dopaminergic receptor agonist and a SSRI or either drug alone for a period of 6 weeks Acute efficacy will be determined by demonstrating a greater remission rate using specified criteria Approximately 115 patients with acute major depression will be enrolled in the study
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 |
|---|---|---|---|
| 04-M-0227 | None | None | None |