Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113022
Status:
TERMINATED
Last Update Posted:
2012-07-13
First Post:
2005-06-02
Brief Title:
Org 24448 to Treat Major 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 and Safety of an AMPAkine Org 24448 in Major Depressive Disorder A Double-Blind Placebo-Controlled Randomized Study
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to concerns about adverse events in separate study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of the experimental drug Org 24448 for short-term treatment of depression It will examine the effects of the drug on symptoms such as low mood and persistent sadness poor sleep and appetite poor motivation and lack of enjoyment of things people normally enjoy negative thinking and feeling slowed down or having trouble concentrating It will also assess whether the drug improves cognitive function especially memory
Patient with major depression who do not have a serious unstable medical illness and who are 21 to 55 years of age may be eligible for this study Candidates are screened with a psychiatric and medical history diagnostic interview physical examination electrocardiogram blood tests and for women a pregnancy test
Participants are tapered off anti-depression drugs and any other medications not allowed on the study over a 3-week period and then begin a 2-week drug-free period During these 2 weeks they have an electroencephalogram EEG with light stimulation and those whose EEG indicates a seizure disorder are excluded from the study Also at the beginning of the drug-free period they begin taking a placebo sugar pill twice a day After 2 weeks on placebo some patients begin treatment with Org 24448 while others remain on placebo They continue the medication for 8 weeks during which time they have a weekly check of vital signs blood and urine tests and rating scales for depression and anxiety Level of functioning is evaluated twice during the study After 8 weeks of treatment patients have a physical exam electrocardiogram ECG EEG blood tests and begin to come off the study drug tapering the medication over a week
In addition to the above procedures some patients undergo the following tests during the 2-week drug-free period and again toward the end of the 8-week medication phase
Neuropsychological testing including measurements of cognitive abilities such as memory attention problem-solving and language skills
Positron emission tomography PET This nuclear medicine test provides information about different brain regions The patient lies on a table in the PET scanner similar to a computed tomography CT scanner with a mask placed over his or her face that helps keep the head still A sugar fluid with a radioactive material attached to it is injected into a catheter plastic tube that has been inserted into a vein in the patients arm The scanner detects
Patient with major depression who do not have a serious unstable medical illness and who are 21 to 55 years of age may be eligible for this study Candidates are screened with a psychiatric and medical history diagnostic interview physical examination electrocardiogram blood tests and for women a pregnancy test
Participants are tapered off anti-depression drugs and any other medications not allowed on the study over a 3-week period and then begin a 2-week drug-free period During these 2 weeks they have an electroencephalogram EEG with light stimulation and those whose EEG indicates a seizure disorder are excluded from the study Also at the beginning of the drug-free period they begin taking a placebo sugar pill twice a day After 2 weeks on placebo some patients begin treatment with Org 24448 while others remain on placebo They continue the medication for 8 weeks during which time they have a weekly check of vital signs blood and urine tests and rating scales for depression and anxiety Level of functioning is evaluated twice during the study After 8 weeks of treatment patients have a physical exam electrocardiogram ECG EEG blood tests and begin to come off the study drug tapering the medication over a week
In addition to the above procedures some patients undergo the following tests during the 2-week drug-free period and again toward the end of the 8-week medication phase
Neuropsychological testing including measurements of cognitive abilities such as memory attention problem-solving and language skills
Positron emission tomography PET This nuclear medicine test provides information about different brain regions The patient lies on a table in the PET scanner similar to a computed tomography CT scanner with a mask placed over his or her face that helps keep the head still A sugar fluid with a radioactive material attached to it is injected into a catheter plastic tube that has been inserted into a vein in the patients arm The scanner detects
Detailed Description:
Depression is a devastating illness that is estimated to affect 12 to 17 of the population at some point during the lifetime of an individual 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 Thus there is a clear need to develop novel and improved therapeutics for major depression Current pathophysiological theories regarding the neurobiology of depression include alterations in intracellular signaling cascades and impairments of cellular plasticity and resilience There is recent evidence suggesting that promoting growth factors such as brain derived neurotrophic factor BDNF may provide a mechanism for the treatment of depression New information indicating modulation of glutamate receptors in the actions of antidepressant treatments suggests a novel approach to develop a new class of antidepressants Studies have shown that the biarylpropylsulfonamide AMPA 2-amino-3-5-methyl-3-oxo-12-oxazol-4-yl propanoic acid receptor potentiators LY392098 and LY451616 have antidepressant effects in animal models of depression Several studies have demonstrated that AMPA receptor activation can increase expression of BDNF both in vitro and in vivo Thus one possible new approach for the treatment of depression is to use an AMPA receptor potentiator
In this study we propose to compare the ampakine receptor potentiator Org 24448 to placebo for the treatment of Major Depression Inpatients and outpatients primarily outpatients ages 21 to 70 with a diagnosis of Major Depression without psychotic features will be randomized to double-blind treatment to either Org 24448 or placebo for a period of 8 weeks Acute efficacy will be determined by demonstrating a greater response rate using specified criteria Approximately 90 patients with acute major depression will be enrolled in the study in order to reach the goal of randomizing 70 patients in the controlled trial
In this study we propose to compare the ampakine receptor potentiator Org 24448 to placebo for the treatment of Major Depression Inpatients and outpatients primarily outpatients ages 21 to 70 with a diagnosis of Major Depression without psychotic features will be randomized to double-blind treatment to either Org 24448 or placebo for a period of 8 weeks Acute efficacy will be determined by demonstrating a greater response rate using specified criteria Approximately 90 patients with acute major depression will be enrolled in the study in order to reach the goal of randomizing 70 patients in the controlled trial
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 |
|---|---|---|---|
| 05-M-0161 | OTHER | CNS-IRB NIH | None |