Trial Outcomes & Findings for Quantitative Electroencephalogram (QEEG) Predictors of Response to Psychotherapy Versus Antidepressant Treatment in Depression (NCT NCT00824044)

NCT ID: NCT00824044

Last Updated: 2018-01-05

Results Overview

The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 39 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2018-01-05

Participant Flow

The first patient was screened on January 6, 2009, and the last patient was screened on October 26, 2010. The study was completed at the Depression Clinical and Research Program at Massachusetts General Hospital.

Participant milestones

Measure	Escitalopram The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.	Cognitive Behavioral Therapy (CBT) The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.
Overall Study STARTED	16	23
Overall Study COMPLETED	10	14
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age data unavailable for 2 participants

Baseline characteristics by cohort

Measure	Cognitive Behavioral Therapy (CBT) n=23 Participants The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.	Escitalopram n=16 Participants The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.	Total n=39 Participants Total of all reporting groups
Age, Continuous	44.8 years STANDARD_DEVIATION 14.2 • n=22 Participants • Age data unavailable for 2 participants	43.3 years STANDARD_DEVIATION 15.5 • n=15 Participants • Age data unavailable for 2 participants	43.9 years STANDARD_DEVIATION 14.8 • n=37 Participants • Age data unavailable for 2 participants
Age, Customized <=18 years	0 participants n=23 Participants	0 participants n=16 Participants	0 participants n=39 Participants
Age, Customized Between 18 and 65 years	19 participants n=23 Participants	14 participants n=16 Participants	33 participants n=39 Participants
Age, Customized >=65 years	3 participants n=23 Participants	1 participants n=16 Participants	4 participants n=39 Participants
Age, Customized Age unknown	1 participants n=23 Participants	1 participants n=16 Participants	2 participants n=39 Participants
Sex: Female, Male Female	12 Participants n=23 Participants	9 Participants n=16 Participants	21 Participants n=39 Participants
Sex: Female, Male Male	11 Participants n=23 Participants	7 Participants n=16 Participants	18 Participants n=39 Participants
Region of Enrollment United States	23 participants n=23 Participants	16 participants n=16 Participants	39 participants n=39 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The number of participants for analysis was based on the number of participants who completed treatment (12 weeks of CBT or medication)

The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression.

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=14 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=9 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Hamilton Depression Rating Scale (HAM-D-17) Scores	10.64 units on a scale Standard Deviation 6.44	13.78 units on a scale Standard Deviation 9.40	—	—

PRIMARY outcome

Timeframe: 12 weeks

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Change in Absolute Beta Power in Channel 4	.0930 Hz Standard Deviation .13602	-.0102 Hz Standard Deviation .09301	.0683 Hz Standard Deviation .151	.0056 Hz Standard Deviation .1084

PRIMARY outcome

Timeframe: 12 weeks

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Change between baseline and LOCF in relative power of the theta wave recorded from channel 1 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Change in Absolute Theta Power From Channel 1	.225 Hz Standard Deviation .02765	-.0455 Hz Standard Deviation .07683	.0075 Hz Standard Deviation .0734	.003 Hz Standard Deviation .0535

PRIMARY outcome

Timeframe: 12 weeks

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Change between baseline and LOCF in relative power of the theta wave recorded from channel 3 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Change in Relative Theta Power Channel 3	.0362 Hz Standard Deviation .04460	-.0090 Hz Standard Deviation .0859	.0015 Hz Standard Deviation .02993	.272 Hz Standard Deviation .06577

PRIMARY outcome

Timeframe: 12 weeks

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Change between baseline and LOCF in relative power of the theta wave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG.

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Change in Relative Theta Power From Channel 4	.0336 Hz Standard Deviation .04428	-.0009 Hz Standard Deviation .03210	.0076 Hz Standard Deviation .03678	.0070 Hz Standard Deviation .04429

PRIMARY outcome

Timeframe: 12 weeks

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Change between baseline and LOCF in relative power of the beetawave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the beta wave compared with the total power in the patient's EEG.

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Change in Relative Beta Power From Channel 4	.0483 Hz Standard Deviation .03560	.0173 Hz Standard Deviation .02921	.0063 Hz Standard Deviation .03758	.0179 Hz Standard Deviation .02929

PRIMARY outcome

Timeframe: 12 weeks

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Change between baseline and LOCF in absolute power of the beta wave recorded from the ear channel of the EEG. The ear channel refers to the average of channels 3 and 4.

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Change in Absolute Beta Power From the Ear Channel	.0537 Hz Standard Deviation .08943	-.0167 Hz Standard Deviation .07461	.0670 Hz Standard Deviation .14412	-.01401 Hz Standard Deviation .08307

PRIMARY outcome

Timeframe: 12 weeks

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Change between baseline and LOCF in relative power of the theta wave recorded from the temporal channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The temporal channel refers to the average of channels 1 and 2

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Change in Relative Theta Power From Temporal Channel	.0182 Hz Standard Deviation .02003	-.0159 Hz Standard Deviation .03422	.0125 Hz Standard Deviation .07914	.0027 Hz Standard Deviation .03688

PRIMARY outcome

Timeframe: 12 weeks

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Change between baseline and LOCF in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Change in Relative Theta Power From Ear Channel	.0349 Hz Standard Deviation .04440	-.0050 Hz Standard Deviation .03487	.0046 Hz Standard Deviation .02858	.0171 Hz Standard Deviation .04103

PRIMARY outcome

Timeframe: 1 week

Population: EEG data only available for 11 participants from CBT arm and 11 participants from Medication arm

Percent change between baseline and week 1 in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4

Outcome measures

Measure	Cognitive Behavioral Therapy (CBT) n=5 Participants Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Escitalopram n=6 Participants Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.	Non Responders in Medication Arm n=5 Participants Individuals randomized to the CBT group who did not respond to the Medication treatment. Response defined as greater than 50% reduction in HAM D scores	Responders in Medication Arm n=6 Participants Individuals randomized to the medication group who did respond to the medication treatment. Response defined as greater than 50% reduction in HAM D scores
Percent Change in Relative Theta Power From Week 1 of the Ear Channel	44.1809 percent Standard Deviation 42.17256	8 percent Standard Deviation 27.45993	7.5180 percent Standard Deviation 29.37028	23.3718 percent Standard Deviation 41.25936

Adverse Events

Cognitive Behavioral Therapy (CBT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Escitalopram

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cognitive Behavioral Therapy (CBT) n=23 participants at risk The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT.	Escitalopram n=16 participants at risk The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will be seen every two weeks by a study physician.
Gastrointestinal disorders Nausea	0.00% 0/23	18.8% 3/16 • Number of events 3
General disorders Headache	0.00% 0/23	25.0% 4/16 • Number of events 5
Nervous system disorders syncopal episode	0.00% 0/23	6.2% 1/16 • Number of events 1
General disorders insomnia	0.00% 0/23	6.2% 1/16 • Number of events 1
General disorders dry mouth	0.00% 0/23	18.8% 3/16 • Number of events 3
Reproductive system and breast disorders irregular menses	0.00% 0/23	6.2% 1/16 • Number of events 1
Musculoskeletal and connective tissue disorders knee aching	0.00% 0/23	6.2% 1/16 • Number of events 1
Musculoskeletal and connective tissue disorders shoulder pain	0.00% 0/23	6.2% 1/16 • Number of events 1
General disorders migraines	0.00% 0/23	6.2% 1/16 • Number of events 1
Gastrointestinal disorders diarrhea	0.00% 0/23	12.5% 2/16 • Number of events 2
General disorders sedation	0.00% 0/23	6.2% 1/16 • Number of events 1
General disorders sweatiness	0.00% 0/23	12.5% 2/16 • Number of events 2
General disorders sleepiness	0.00% 0/23	12.5% 2/16 • Number of events 3
Respiratory, thoracic and mediastinal disorders upper respiratory infection	0.00% 0/23	6.2% 1/16 • Number of events 1
Gastrointestinal disorders vomiting	0.00% 0/23	6.2% 1/16 • Number of events 1
General disorders fidgetiness	0.00% 0/23	6.2% 1/16 • Number of events 1

Additional Information

Dr. Amy Farabaugh

Massachusetts General Hospital

Phone: 617-726-1629

Email: afarabaugh@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place