Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT02330679

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 20 - 55

Healthy Volunteers: Not accepted

Interventions

Desvenlafaxine

Placebo

Study Details

Brief summary:

Despite significant advances in pharmacological treatment, the global burden of depression is increasing worldwide. The major challenge in antidepressant treatment is the clinicians' inability to predict the variability in individual response to the treatment. The development of biomarkers to predict treatment outcomes would enable clinician to find the right medication for a particular patient at the early stage of the treatment and thus could reduce prolonged suffering and ineffective protracted treatment. Brain imaging studies that examined brain predictors of treatment response based on group comparisons have limited value in classifying individuals as responders or non-responders. Machine learning classification techniques such as the support vector machine (SVM) method have proven useful in the classification of individual brain image observations into distinct groups or classes. However, studies that have applied the SVM method to structural and functional magnetic resonance scans (fMRI) involved small sample sizes and were confounded by placebo responses. Furthermore, a recent meta-analysis of clinical trials and EEG studies have shown that early clinical responses and brain changes at the early phase of antidepressant treatment may predict later clinical outcomes suggesting that neural markers measured in the early phase of antidepressant treatment may improve predictive accuracy. However, there is no fMRI study to date that has examined the predictive accuracy of data obtained in early phase of the treatment. We have preliminary fMRI data relating to early treatment response that form the basis of this proposed study.

The main objective of this study is to use machine learning method to examine the predictive value (sensitivity, specificity, accuracy) of resting state and emotional task-related fMRI data collected at pre-treatment baseline (week 0) and in the early phase of antidepressant treatment (week 2) in the classification of remitters (< 10 MADRS scores after 12 weeks of treatment) and non-remitters in patients with major depressive disorder (MDD). A secondary objective is to determine which data set (week 0 or week 2) gives the best predictive value.

Conditions

Major Depressive Disorder

Study ID

NCT02330679

Start date

Dec, 2014

Status verified date

Dec, 2014

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Acute episode of major depressive disorder of unipolar subtype and a score of 22 or higher in the Montgomery-Asberg Depression Rating (MADRS) scale
2. Free of psychotropic medication for a minimum of 4 weeks at recruitment

Exclusion Criteria:

1. Axis I disorders such as bipolar disorder, anxiety disorders, psychosis or history of substance abuse within 6 months of study participation
2. severe borderline personality disorder
3. severe medical and neurological disorders
4. severe suicidal patients
5. failure to respond to three trials of antidepressant medication
6. subjects who arecontraindicated for MRI. Subjects considered unsuitable for MRI include those with cardiac pacemakers, neural pacemakers, surgical clips, metal implants, cochlear implants, or metal objects or particles in their body. Pregnancy, a history of claustrophobia, weight over 250 lb, or uncorrected vision will also be causes of exclusion for participation.

Study Design

Enrollment

61 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Desvenlafaxine

2-week single-blind placebo run-in phase followed by a 12-week open-label trial with desvenlafaxine

Interventions

Desvenlafaxine

The intervention will consist of a 2-week single-blind placebo run-in phase followed by a 12-week open-label trial with desvenlafaxine (a SNRI medication)

Placebo

Primary outcome measure

  • The resting state and emotional task related brain activity pattern at the pretreatment baseline and two weeks post treatment as measured by functional MRI and analyzed by machine learning techniques [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Rajamannar Ramasubbu, MD, FRCP(C)

403-210-6890rramasub@ucalgary.ca

Locations

University of Calgary, TRW Building, Foothills Hospital Campus

Recruiting

Calgary, Alberta, Canada, T2N4Z6

Contacts

Rajamannar Ramasubbu, MD, FRCP(C)

403-210-6890rramasub@ucalgary.ca

Principal Investigator:

Rajamannar Ramasubbu, MD, FRCP(C)

University of Calgary: Foothills Hospital

Recruiting

Calgary, Alberta, Canada, T2N4Z6

Principal Investigator:

Rajamannar Ramasubbu, MD, FRCP(C)

More Information

Sponsor

University of Calgary

Last update posted

Jan 5, 2015

Last verified

Dec, 2014

Keywords

  • Major Depression, Neuroimaging, Desvenlafaxine, Machine learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2015-01-05.