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Electroencephalography (EEG) Signal Processing (EEG-SP)

This study is currently recruiting participants.
Verified November 2011 by St. Joseph's Healthcare Hamilton
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
History of Changes
  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:

U.S. FDA Resources

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
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:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Citalopram
Venlafaxine
Bupropion
Duloxetine
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013