Trial Outcomes & Findings for Imaging Predictors of Treatment Response in Depression (NCT NCT00367341)

NCT ID: NCT00367341

Last Updated: 2014-01-09

Results Overview

\# of study participants with Hamilton Depression-17-item score less than or equal to 7.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 82 participants
• Primary outcome timeframe: Measured at week 12
• Results posted on: 2014-01-09

Participant Flow

Participant milestones

Measure	Escitalopram escitalopram : Participants will receive treatment with escitalopram for 12 weeks.	Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Overall Study STARTED	42	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Escitalopram escitalopram : Participants will receive treatment with escitalopram for 12 weeks.	Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	1	0

Baseline Characteristics

Imaging Predictors of Treatment Response in Depression

Baseline characteristics by cohort

Measure	Escitalopram n=42 Participants escitalopram : Participants will receive treatment with escitalopram for 12 weeks.	Cognitive Behavioral Therapy n=40 Participants Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41.2 years STANDARD_DEVIATION 6.8 • n=5 Participants	42.2 years STANDARD_DEVIATION 9.5 • n=7 Participants	41.68 years STANDARD_DEVIATION 8.22 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	40 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at week 12

Population: completed study participants in 12-week-trial

# of study participants with Hamilton Depression-17-item score less than or equal to 7.

Outcome measures

Measure	Escitalopram n=32 Participants escitalopram : Participants will receive treatment with escitalopram for 12 weeks.	Cognitive Behavioral Therapy n=31 Participants Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks	12 participants	12 participants

SECONDARY outcome

Timeframe: Measured at week 12.

Population: completers

Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score

Outcome measures

Measure	Escitalopram n=32 Participants escitalopram : Participants will receive treatment with escitalopram for 12 weeks.	Cognitive Behavioral Therapy n=31 Participants Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks	18 participants	18 participants

Adverse Events

Escitalopram

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Escitalopram n=42 participants at risk escitalopram : Participants will receive treatment with escitalopram for 12 weeks.	Cognitive Behavioral Therapy n=40 participants at risk Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Gastrointestinal disorders diarrhea	11.9% 5/42 • Number of events 5	5.0% 2/40 • Number of events 2
General disorders fatigue	11.9% 5/42 • Number of events 5	5.0% 2/40 • Number of events 2
Infections and infestations flu	7.1% 3/42 • Number of events 3	0.00% 0/40
General disorders dizziness	11.9% 5/42 • Number of events 5	0.00% 0/40
General disorders dry mouth	7.1% 3/42 • Number of events 3	0.00% 0/40
General disorders headache	33.3% 14/42 • Number of events 14	10.0% 4/40 • Number of events 4
Gastrointestinal disorders indigestion	9.5% 4/42 • Number of events 4	5.0% 2/40 • Number of events 2
General disorders nausea	23.8% 10/42 • Number of events 10	10.0% 4/40 • Number of events 4
Skin and subcutaneous tissue disorders rash	0.00% 0/42	10.0% 4/40 • Number of events 4
Gastrointestinal disorders stomach cramps	0.00% 0/42	5.0% 2/40 • Number of events 2
Gastrointestinal disorders constipation	11.9% 5/42 • Number of events 5	0.00% 0/40
Respiratory, thoracic and mediastinal disorders upper respiratory infection	9.5% 4/42 • Number of events 4	22.5% 9/40 • Number of events 9
General disorders insomnia	16.7% 7/42 • Number of events 7	0.00% 0/40
General disorders decreased libido	14.3% 6/42 • Number of events 6	0.00% 0/40
General disorders sedation	26.2% 11/42 • Number of events 11	0.00% 0/40

Additional Information

Helen Mayberg, MD

Emory University School of Medicine

Phone: 404-727-6740

Email: hmayber@emory.edu

Results disclosure agreements

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