Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025792
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-10-24
Brief Title:
Clinical Trial of Pramipexole in Bipolar Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Investigation of the Antidepressant Efficacy of a Dopamine Agonist With Neurotrophic Properties in Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2005-11
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:
The purpose of this study is to examine the safety and effectiveness of the drug pramipexole given in combination with lithium or divalproex for the short-term treatment of acute depression in patients with bipolar disorder
Bipolar disorder is a severe chronic and often life-threatening illness Treatments for acute unipolar depression have been extensively researched However despite the availability of a wide range of antidepressant drugs a significant proportion of depressed patients fail to respond to first-line antidepressant treatment Novel and improved therapeutics for bipolar depression are needed This study will evaluate the antidepressant properties of pramipexole
This study will be conducted in three phases Phase 1 is a 14-day washout period in which participants will be tapered off all their psychiatric medicines except divalproex or lithium Participants will also be asked to adhere to a low caffeine and low monoamine diet During Phase 2 participants will be randomly assigned to receive either pramipexole or placebo an inactive pill for 6 weeks Participants who respond to treatment will be given either open-label pramipexole or another clinical treatment
Participants will be screened with a medical history physical examination electrocardiogram EKG blood and urine tests and a psychiatric evaluation Women of childbearing potential will have a pregnancy test Participants will have a physical exam and EKG at study entry and study completion Blood will be drawn at various times throughout the study Pulse and blood pressure measurements will be taken daily Weekly interviews will be conducted Participants and a control group of healthy volunteers will undergo positron emission tomography PET and magnetic resonance imaging MRI scans of the brain
Bipolar disorder is a severe chronic and often life-threatening illness Treatments for acute unipolar depression have been extensively researched However despite the availability of a wide range of antidepressant drugs a significant proportion of depressed patients fail to respond to first-line antidepressant treatment Novel and improved therapeutics for bipolar depression are needed This study will evaluate the antidepressant properties of pramipexole
This study will be conducted in three phases Phase 1 is a 14-day washout period in which participants will be tapered off all their psychiatric medicines except divalproex or lithium Participants will also be asked to adhere to a low caffeine and low monoamine diet During Phase 2 participants will be randomly assigned to receive either pramipexole or placebo an inactive pill for 6 weeks Participants who respond to treatment will be given either open-label pramipexole or another clinical treatment
Participants will be screened with a medical history physical examination electrocardiogram EKG blood and urine tests and a psychiatric evaluation Women of childbearing potential will have a pregnancy test Participants will have a physical exam and EKG at study entry and study completion Blood will be drawn at various times throughout the study Pulse and blood pressure measurements will be taken daily Weekly interviews will be conducted Participants and a control group of healthy volunteers will undergo positron emission tomography PET and magnetic resonance imaging MRI scans of the brain
Detailed Description:
Bipolar affective disorder BPD manic-depressive illness is a common severe chronic and often life-threatening illness Increasingly it is being recognized that it is the depressive phase of the illness which contributes much of the morbidity and mortality Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses Suicide is the cause of death in 10-20 of individuals with either bipolar or recurrent depressive disorders
The treatments for acute unipolar depression have been extensively researched However despite the availability of a wide range of antidepressant drugs clinical trials indicate that 30 to 40 of unipolar depressed patients fail to respond to first-line antidepressant treatment despite adequate dosage duration and compliance Very few studies have examined the efficacy of somatic treatments for the acute phase of bipolar depression Thus there is a clear need to develop novel and improved therapeutics for bipolar depression A deficiency of dopamine systems stands as a prime candidate for involvement in the pathophysiology of depression
Preliminary studies suggest that pramipexole Mirapex a dopaminergic-agent that is FDA-approved for Parkinsons Disease may have antidepressant properties in unipolar and bipolar patients as well as neurotrophic properties In this study we propose to investigate the potential efficacy of pramipexole which enhances dopaminergic throughput via D2 and D3 receptors and exerts robust neurotrophic effects via direct intracellular mechanisms
This is a 6-week randomized double-blind placebo-controlled add-on study that will examine the efficacy of pramipexole in acutely depressed Bipolar II patients
This study has three phases The first phase is the washout phase that will last for 14 days The second phase is a 6-week double-blind acute phase in which the efficacy and tolerability of adjunctive pramipexole and placebo are compared Patients who complete the 6-week double-blind phase will receive either open-label pramipexole or clinical treatment Acute efficacy will be determined by demonstrating a greater response rate using specified criteria
Patients ages 18 to 70 with a diagnosis of Bipolar II disorder depressed without psychotic features will be randomized to double-blind treatment to receive either pramipexole 0375-45 mgday or placebo in combination with a mood stabilizer for a period of 6 weeks Following this acute period the patients will receive either open-label pramipexole or treatment as clinically indicated Approximately 100 patients with acute Bipolar II depression will be enrolled in the study Imaging and pharmacokinetic studies will be obtained during the study
The treatments for acute unipolar depression have been extensively researched However despite the availability of a wide range of antidepressant drugs clinical trials indicate that 30 to 40 of unipolar depressed patients fail to respond to first-line antidepressant treatment despite adequate dosage duration and compliance Very few studies have examined the efficacy of somatic treatments for the acute phase of bipolar depression Thus there is a clear need to develop novel and improved therapeutics for bipolar depression A deficiency of dopamine systems stands as a prime candidate for involvement in the pathophysiology of depression
Preliminary studies suggest that pramipexole Mirapex a dopaminergic-agent that is FDA-approved for Parkinsons Disease may have antidepressant properties in unipolar and bipolar patients as well as neurotrophic properties In this study we propose to investigate the potential efficacy of pramipexole which enhances dopaminergic throughput via D2 and D3 receptors and exerts robust neurotrophic effects via direct intracellular mechanisms
This is a 6-week randomized double-blind placebo-controlled add-on study that will examine the efficacy of pramipexole in acutely depressed Bipolar II patients
This study has three phases The first phase is the washout phase that will last for 14 days The second phase is a 6-week double-blind acute phase in which the efficacy and tolerability of adjunctive pramipexole and placebo are compared Patients who complete the 6-week double-blind phase will receive either open-label pramipexole or clinical treatment Acute efficacy will be determined by demonstrating a greater response rate using specified criteria
Patients ages 18 to 70 with a diagnosis of Bipolar II disorder depressed without psychotic features will be randomized to double-blind treatment to receive either pramipexole 0375-45 mgday or placebo in combination with a mood stabilizer for a period of 6 weeks Following this acute period the patients will receive either open-label pramipexole or treatment as clinically indicated Approximately 100 patients with acute Bipolar II depression will be enrolled in the study Imaging and pharmacokinetic studies will be obtained during 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 |
|---|---|---|---|
| 02-M-0018 | None | None | None |