Trial Outcomes & Findings for Biological Markers of Response to Treatment in Major Depressive Disorder (NCT NCT00361218)

Results Overview

"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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

72 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-05-11

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Open-label Selective Serotonin Reuptake Inhibitor (SSRI) citalopram or escitalopram open-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.
Overall Study STARTED	53
Overall Study Completed Baseline Assessment	47
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label Selective Serotonin Reuptake Inhibitor (SSRI) citalopram or escitalopram open-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.
Overall Study Lost to Follow-up	11
Overall Study Personal Reasons	7
Overall Study terminated / withdrawn due to toxicity /	5

Baseline Characteristics

Biological Markers of Response to Treatment in Major Depressive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label SSRI n=47 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	43.3 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Open-label Selective Serotonin Reuptake Inhibitor (SSRI) n=28 Participants citalopram or escitalopram open-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.
Serum Brain-derived Neurotrophic Factor (BDNF) Levels Pre-SSRI BDNF Level	6077.270 pg/mL Standard Deviation 4371.67
Serum Brain-derived Neurotrophic Factor (BDNF) Levels Post-SSRI BDNF Level	4393.24 pg/mL Standard Deviation 3263.70

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome data not reported

Adverse Events

Open-label SSRI

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open-label SSRI n=47 participants at risk 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.
Metabolism and nutrition disorders weight gain	2.1% 1/47 • Number of events 1 • 8 weeks
Metabolism and nutrition disorders lack of appetite	2.1% 1/47 • Number of events 1 • 8 weeks
Musculoskeletal and connective tissue disorders increase in tremors	2.1% 1/47 • Number of events 1 • 8 weeks
Gastrointestinal disorders nausea	2.1% 1/47 • Number of events 1 • 8 weeks
Psychiatric disorders hypomania	2.1% 1/47 • Number of events 1 • 8 weeks

Additional Information

John W. Denninger, MD, PhD

Massachusetts General Hospital

Phone: 617-726-2985

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place