Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108316
Status:
WITHDRAWN
Last Update Posted:
2013-09-27
First Post:
2005-04-14
Brief Title:
Determinants in Antidepressant Outcomes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
SERT Affinity Determinants in Antidepressant Outcomes
Status:
WITHDRAWN
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study PI resigned
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to understand if a biological measurement of how platelets respond to serotonin a chemical in the blood sometimes referred to as SERT can provide information that will determine an ideal dose one specifically tailored for each individuals chemistry The biological measurement will be obtained by testing a blood sample There will be approximately 120 control subjects expected for enrollment
Detailed Description:
OBJECTIVE The objective of this dose-ranging three-arm study of fluoxetine is to study the kinetics of the serotonin transporter in platelets and relate this to antidepressant response by comparing the manipulation of serotonin and platelet measure to standard treatment as it now exists
RESEARCH PLAN The project will examine two methods of dose adjustment of selective serotonin reuptake inhibitor SSRI treatment The first method emulates the current standard clinical practice ie titrating the dosage based upon the subjects current depression symptomatology standard treatment arm The second method utilizes the measurement of the Km to create a dosage tailored to the individual to approach the optimum treatment Kapp biological treatment arm Additionally the placebo arm will control for treatment failure and high placebo response This application is a double-blind placebo controlled randomized dose ranging study in male and female outpatients with Major Depressive Disorder The proposed study will take place over a period of 12 weeks recruiting 117 subjects in order to achieve 90 completers 30 in each arm assuming 30 dropout rate over a five year period who are diagnosed with Major Depression according to DSM-IV criteria Following a 1 week screening period during which safety assessments are completed and evaluated and the Km and dosage are calculated the subjects will be blindly randomized in a 111 ratio to either the standard treatment the biological arm or the placebo arm Subjects will return to the clinic at weeks 4 8 and 12 for ratings and platelet Km determinations Response will be measured and dosage adjustment will be made at weeks 4 and 8 A final determination of response will be made at week 12
METHODS Responders will be identified according to conventional criteria will be defined as those subject who 1 have a 50 or more improvement from baseline scores as measured on the Hamilton Depression Scale HAM-D 2 no longer meet Major Depressive criteria according to DSM-IV and 3 score 10 on the HAM-D 17 item or 15 on the 24-item HAM-D The efficacy measures will be the Hamilton Depression Scale HAM-D The seventeen item scale is designed to measure depression level Montgomery-Asberg Depression Rating Scale MADRS A scale designed to provide additional subjective information to determine depressive symptoms The Profile of Mood States POMS and the Cloninger Temperament Character Index TCI are patient rated scales which measure feelings and personality traits The safety parameters include physical examinations vital signs collection of adverse events and 12-lead electrocardiogram ECG and clinical laboratory assessments
CLINICAL RELEVANCE Previous studies have indicated fluoxetine is an effective treatment for depression This study is designed to provide additional information concerning the methods for determining dose Potentially the information gained from this research may provide a more cost-effective way of finding an effective dose than the trial and error approach generally used
RESEARCH PLAN The project will examine two methods of dose adjustment of selective serotonin reuptake inhibitor SSRI treatment The first method emulates the current standard clinical practice ie titrating the dosage based upon the subjects current depression symptomatology standard treatment arm The second method utilizes the measurement of the Km to create a dosage tailored to the individual to approach the optimum treatment Kapp biological treatment arm Additionally the placebo arm will control for treatment failure and high placebo response This application is a double-blind placebo controlled randomized dose ranging study in male and female outpatients with Major Depressive Disorder The proposed study will take place over a period of 12 weeks recruiting 117 subjects in order to achieve 90 completers 30 in each arm assuming 30 dropout rate over a five year period who are diagnosed with Major Depression according to DSM-IV criteria Following a 1 week screening period during which safety assessments are completed and evaluated and the Km and dosage are calculated the subjects will be blindly randomized in a 111 ratio to either the standard treatment the biological arm or the placebo arm Subjects will return to the clinic at weeks 4 8 and 12 for ratings and platelet Km determinations Response will be measured and dosage adjustment will be made at weeks 4 and 8 A final determination of response will be made at week 12
METHODS Responders will be identified according to conventional criteria will be defined as those subject who 1 have a 50 or more improvement from baseline scores as measured on the Hamilton Depression Scale HAM-D 2 no longer meet Major Depressive criteria according to DSM-IV and 3 score 10 on the HAM-D 17 item or 15 on the 24-item HAM-D The efficacy measures will be the Hamilton Depression Scale HAM-D The seventeen item scale is designed to measure depression level Montgomery-Asberg Depression Rating Scale MADRS A scale designed to provide additional subjective information to determine depressive symptoms The Profile of Mood States POMS and the Cloninger Temperament Character Index TCI are patient rated scales which measure feelings and personality traits The safety parameters include physical examinations vital signs collection of adverse events and 12-lead electrocardiogram ECG and clinical laboratory assessments
CLINICAL RELEVANCE Previous studies have indicated fluoxetine is an effective treatment for depression This study is designed to provide additional information concerning the methods for determining dose Potentially the information gained from this research may provide a more cost-effective way of finding an effective dose than the trial and error approach generally used
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