Recruiting

EEG Signal Processing

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT01369290

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Venlafaxine

bupropion

escitalopram

Psychotherapy

Duloxetine

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder

Study ID

NCT01369290

Start date

Oct, 2009

Status verified date

Nov, 2011

Completion date

Oct, 2013

Anticipated

Primary completion date

Oct, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Drug 1

Venlafaxine

Drug 2

Bupropion

Drug 3

Escitalopram

Drug 4

Duloxetine

Psychotherapy

Cognitive behaviour therapy

Interventions

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.

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.

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.

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.

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.

Primary outcome measure

  • Machine learning [ Time Frame: 6 weeks with medication, or 12 weeks with CBT ]

Central Contacts and Locations

Central contacts

Rose Marie Mueller, RN

905-522-1155rmueller@stjoes.ca

Locations

St. Joseph's Healthcare, Centre for Mountain Health Services

Recruiting

Hamilton, Ontario, Canada, L8N 3K7

Contacts

Rose Marie Mueller, RN

905-522-1155rmueller@stjoes.ca

Principal Investigator:

Gary M Hasey, MD

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Nov 30, 2011

Last verified

Nov, 2011

Keywords

  • Depression
  • Antidepressant Medication
  • CBT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2011-11-30.