Major Depressive Disorder
Conditions
Keywords
depression, biology
Brief summary
The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).
Detailed description
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain. It often takes several weeks to find out if an antidepressant medication is going to work for someone. This research study aims to identify tests that are able to predict if a medication will work, even before a person starts to feel better. The first test is a measurement of the blood protein Brain-Derived Neurotrophic Factor (BDNF), which is involved with brain cell growth. The second test is a Quantitative Electroencephalogram (QEEG), which measures brain activity. The study lasts for 8 weeks and involves 5 total visits to the clinic. Throughout the study, all subjects will receive either escitalopram (Lexapro) or citalopram (Celexa) on the basis of the study doctor's clinical judgment. The dose of the medications can be increased at any point in time if the study doctor thinks it is appropriate. After the first screen visit (which lasts about 3 hours), each subsequent half-hour visit will involve a 2-tablespoon blood draw to measure BDNF levels, as well as a QEEG in which small, painless electrodes are stuck to the subject's forehead and electrical activity of the brain is measured. At the end of the 8 weeks, subjects are offered 3 months of free follow-up care, including medications.
Interventions
DRUGopen-label selective serotonin reuptake inhibitor (SSRI)
Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-65 * Meet criteria for current Major Depressive Disorder * Antidepressant medication-free for at least 2 weeks prior to the start of the study
Exclusion criteria
* Pregnant or breastfeeding women * Anyone who is suicidal * Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania * Anyone currently taking an SSRI * Past intolerance to Lexapro or Celexa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Brain-derived Neurotrophic Factor (BDNF) Levels | 8 weeks | Pre-SSRI BDNF Level refers to the data collection point before SSRI intake and Post-SSRI BDNF Level refers to the data collection point 8 weeks after SSRI intake. |
| Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response | 8 weeks | Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation. Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression). |
Participant flow
Recruitment details
Subjects were recruited from Boston/Salem Metropolitan Area via advertising on newspapers, television and radio, referrals from other clinicians, and patients who came into the Depression Research Program to participate in other studies
Pre-assignment details
After consenting to participate, subjects were screened for the study and, if found to be eligible, returned for their baseline visit after one week, during which no psychotropic medication was allowed.
Participants by arm
| Arm | Count |
|---|---|
| Open-label SSRI citalopram or escitalopram
open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion. | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Personal Reasons | 7 |
| Overall Study | terminated / withdrawn due to toxicity / | 5 |
Baseline characteristics
| Characteristic | Open-label SSRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants |
| Age, Continuous | 43.3 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response
Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation. Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression).
Time frame: 8 weeks
Population: QEEG data were collected, analyzed and reported as part of a larger trial. The analysis of QEEG data per protocol was only possible using the proprietary algorithm developed by a company; acquisition of that company precludes analysis for this study alone. Larger study reported in: Iosifescu DV et al. Eur Neuropsychopharmacol. 2009;19:772-7.
Primary
Serum Brain-derived Neurotrophic Factor (BDNF) Levels
Pre-SSRI BDNF Level refers to the data collection point before SSRI intake and Post-SSRI BDNF Level refers to the data collection point 8 weeks after SSRI intake.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open-label Selective Serotonin Reuptake Inhibitor (SSRI) | Serum Brain-derived Neurotrophic Factor (BDNF) Levels | Pre-SSRI BDNF Level | 6077.270 pg/mL | Standard Deviation 4371.67 |
| Open-label Selective Serotonin Reuptake Inhibitor (SSRI) | Serum Brain-derived Neurotrophic Factor (BDNF) Levels | Post-SSRI BDNF Level | 4393.24 pg/mL | Standard Deviation 3263.7 |