Electroencephalography (EEG) Signal Processing (EEG-SP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by St. Joseph's Healthcare Hamilton.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Gary Hasey, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01369290
First received: September 18, 2010
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

Current methods of choosing treatment for major depressive disorder (MDD) are inefficient. The Strategic Treatment to Achieve Remission of Depression (STAR*D) Trial revealed that only about 1/3 of patients treated with antidepressant drugs will go into remission with the first medication chosen. We hypothesize that pattern recognition software using Machine Learning methods can accurately predict response to a variety of antidepressant medications (ADM) or cognitive behavior therapy (CBT) after training using pre-treatment demographic, clinical, laboratory or electroencephalographic (EEG) data. These algorithms might assist the clinician to chose, for any given patient, an antidepressant treatment option with greater probability of favourable response than is achievable using current best practise methods.


Condition Intervention
Major Depressive Disorder
Drug: Venlafaxine
Drug: bupropion
Drug: escitalopram
Other: Psychotherapy
Drug: Duloxetine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EEG Signal Processing as a Predictor of Antidepressant Response

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Machine learning [ Time Frame: 6 weeks with medication, or 12 weeks with CBT ] [ Designated as safety issue: No ]
    The accuracy of the trained predictive model based on machine learning methodology is the primary outcome we are interested in studying. The primary outcome measure, i.e. model performance accuracy, is tested using the jack-knifed "leave N out" nested cross validation method with response being determined using the MDRS scale.


Secondary Outcome Measures:
  • Machine learning [ Time Frame: 6 weeks with medication, 12 weeks with CBT ] [ Designated as safety issue: No ]
    The accuracy of the trained predictive model based on machine learning methodology is the primary outcome we are interested in studying. The primary outcome measure, i.e. model performance accuracy, is tested using the jack-knifed "leave N out" nested cross validation method with response being determined using the Beck II scale.


Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Drug 1
Venlafaxine
Drug: Venlafaxine
75 to 375 mg/day for 6 weeks. If no response at 6 weeks, reassignment to one of the other treatment groups for a further 6 to 12 weeks in phase II.
Other Name: Effexor
Drug 2
Bupropion
Drug: bupropion
150 to 300 mg daily for 6 weeks. If no response at 6 weeks, reassignment to one of the other treatment groups for a further 6 to 12 weeks in phase II.
Other Name: Wellbutrin
Drug 3
Escitalopram
Drug: escitalopram
10 to 30 mg daily for 6 weeks. If no response at 6 weeks, reassignment to one of the other treatment groups for a further 6 to 12 weeks in phase II.
Other Name: Cipralex
Drug 4
Duloxetine
Drug: Duloxetine
30 to 60 mg daily for 6 weeks. If no response at 6 weeks, reassignment to one of the other treatment groups for a further 6 to 12 weeks in phase II.
Other Name: Cymbalta
Psychotherapy
Cognitive behaviour therapy
Other: Psychotherapy
Once weekly CBT psychotherapy session for 12 weeks. If no response at 12 weeks, reassignment to one of the other treatment groups for a further 6 weeks in phase II.
Other Name: CBT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Outpatients with Major Depressive Disorder from the Greater Hamilton Area

Criteria

Inclusion Criteria:

  • Clients with Major Depression
  • Males and Females ages 18 - 70

Exclusion Criteria:

  • Clients who have known neurological problems
  • Clients with a history of severe head injury
  • Clients with strong thoughts of suicide
  • Clients who have had ECT or Cognitive Behavior Therapy within 6 months
  • Females who are sexually active and are not on adequate birth control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369290

Contacts
Contact: Rose Marie Mueller, RN 905-522-1155 ext 36629 rmueller@stjoes.ca

Locations
Canada, Ontario
St. Joseph's Healthcare, Centre for Mountain Health Services Recruiting
Hamilton, Ontario, Canada, L8N 3K7
Contact: Rose Marie Mueller, RN    905-522-1155 ext 36629    rmueller@stjoes.ca   
Principal Investigator: Gary M Hasey, MD         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Gary M Hasey, MD St. Joseph's Healthcare and McMaster University, Hamilton
  More Information

No publications provided

Responsible Party: Gary Hasey, Associate Professor, Department of Psychiatry and Behavioral Neurosciences, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01369290     History of Changes
Other Study ID Numbers: ESP-3152, EEG Signal Processing
Study First Received: September 18, 2010
Last Updated: November 28, 2011
Health Authority: Canada: Health Canada

Keywords provided by St. Joseph's Healthcare Hamilton:
Depression
Antidepressant Medication
CBT

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Bupropion
Citalopram
Dexetimide
Duloxetine
Venlafaxine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014