Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00437827
Status:
COMPLETED
Last Update Posted:
2009-10-27
First Post:
2007-01-17
Brief Title:
rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
Sponsor:
MYnd Analytics
Organization:
MYnd Analytics
Study Overview
Official Title:
A Multicenter Randomized Blinded Controlled Parallel Group Trial to Demonstrate the Efficacy of rEEG Guided Pharmacotherapy of Subjects With Depression Treatment Failure
Status:
COMPLETED
Status Verified Date:
2009-10
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 is testing a process rEEGfor selecting the most appropriate medications to treat a patients depression versus a control group being treated according to a standardized method the modified StarD Algorithm Qualified subjects will be randomized to the experimental rEEG guided group or the control group and treated for 12 weeks Medications utilized in this study are currently marketed All visits physical exam rEEG labs rating scales and medications are provided at no cost to the patient
Detailed Description:
This study is testing a process rEEGfor selecting the most appropriate medications to treat a patients depression versus a control group being treated according to a standardized method the modified StarD Algorithm Qualified subjects will be randomized to the experimental rEEG guided group or the control group and treated for 10 weeks Medications utilized in this study are currently marketed All visits physical exam rEEG labs rating scales and medications are provided at no cost to the patient
To qualify for entry into the study patients must be
1 18 years of age or older
2 Diagnosis of Major Depressive Disorder Subjects may meet criteria for both melancholic and atypical depression
3 Have failed 1 or more SSRIs or have failed 2 or more antidepressants in at least 2 drug classes
And patients must not have
1 History of closed head injury with unconsciousness craniotomy cerebral metastases cerebrovascular accident no current diagnosis of seizure disorder bipolar disorder schizophrenia dementia mental retardation substance abuse or major depression with psychotic features or use of depot neuroleptics in last 12 months
2 Known pregnancy andor lactation or intent to become pregnant during this study
Medications that can be used in this study are
Anti-depressants fluoxetine sertraline paroxetine desipramine imipramine nortriptylineamitriptyline clomipramine bupropion venlafaxine
Stimulants MAO Inhibitors moclobemide tranylcypromine selegiline methylphenidate dextroamphetamine dexlevoamphetamine pemoline lamotrigine topiramate
Benzodiazepines lorazepam clonazepam alprazolam
Anti-convulsants carbamazepine lithium divalproex gabapentin
Beta Blockers metoprolol propranolol atenolol
To qualify for entry into the study patients must be
1 18 years of age or older
2 Diagnosis of Major Depressive Disorder Subjects may meet criteria for both melancholic and atypical depression
3 Have failed 1 or more SSRIs or have failed 2 or more antidepressants in at least 2 drug classes
And patients must not have
1 History of closed head injury with unconsciousness craniotomy cerebral metastases cerebrovascular accident no current diagnosis of seizure disorder bipolar disorder schizophrenia dementia mental retardation substance abuse or major depression with psychotic features or use of depot neuroleptics in last 12 months
2 Known pregnancy andor lactation or intent to become pregnant during this study
Medications that can be used in this study are
Anti-depressants fluoxetine sertraline paroxetine desipramine imipramine nortriptylineamitriptyline clomipramine bupropion venlafaxine
Stimulants MAO Inhibitors moclobemide tranylcypromine selegiline methylphenidate dextroamphetamine dexlevoamphetamine pemoline lamotrigine topiramate
Benzodiazepines lorazepam clonazepam alprazolam
Anti-convulsants carbamazepine lithium divalproex gabapentin
Beta Blockers metoprolol propranolol atenolol
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 |
|---|---|---|---|
| CNSR 010 | None | None | None |