Trial Outcomes & Findings for Improving Therapeutic Learning in Depression: Proof of Concept (NCT NCT02376257)
NCT ID: NCT02376257
Last Updated: 2018-09-19
Results Overview
A modified Cognitive Therapy Awareness Scale (CTAS) was used to assess delayed memory for cognitive therapy content from the computerized CBT. Higher scores indicate better memory for CBT skills. Scores range from 0 to 40.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Week 2 and Week 3
Results posted on
2018-09-19
Participant Flow
Participant milestones
| Measure |
250 mg DCS
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
11
|
|
Overall Study
COMPLETED
|
13
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were obtained on 34 of the 36 participants.
Baseline characteristics by cohort
| Measure |
250 mg DCS
n=13 Participants
Baseline assessment (week 1), two weekly sessions when 250mg DCS is administered, and final week (week 4) when retention is assessed.
250 mg DCS: Drug
|
100 mg Modafinil
n=12 Participants
Baseline assessment (week 1), two weekly sessions when 100 mg modafinil is administered, and final week (week 4) when retention is assessed.
100 mg Modafinil: Drug
|
Placebo
n=11 Participants
Baseline assessment (week 1), two weekly sessions when placebo is administered, and final week (week 4) when retention is assessed.
Placebo: Drug
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=13 Participants
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
36 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 14.0 • n=13 Participants
|
26.4 years
STANDARD_DEVIATION 8.1 • n=12 Participants
|
27.7 years
STANDARD_DEVIATION 10.8 • n=11 Participants
|
29.9 years
STANDARD_DEVIATION 11.7 • n=36 Participants
|
|
Sex/Gender, Customized
Male
|
5 Participants
n=13 Participants
|
5 Participants
n=12 Participants
|
4 Participants
n=11 Participants
|
14 Participants
n=36 Participants
|
|
Sex/Gender, Customized
Female
|
7 Participants
n=13 Participants
|
6 Participants
n=12 Participants
|
7 Participants
n=11 Participants
|
20 Participants
n=36 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
5 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=13 Participants
|
12 Participants
n=12 Participants
|
9 Participants
n=11 Participants
|
31 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=13 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=11 Participants
|
7 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=13 Participants
|
9 Participants
n=12 Participants
|
5 Participants
n=11 Participants
|
22 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=36 Participants
|
|
Immediate Memory measured by the Hopkins Verbal Learning Task
|
8.5 number of correctly recalled words
STANDARD_DEVIATION 1.3 • n=12 Participants • Data were obtained on 34 of the 36 participants.
|
9.6 number of correctly recalled words
STANDARD_DEVIATION 1.1 • n=12 Participants • Data were obtained on 34 of the 36 participants.
|
9.6 number of correctly recalled words
STANDARD_DEVIATION 1.7 • n=10 Participants • Data were obtained on 34 of the 36 participants.
|
9.2 number of correctly recalled words
STANDARD_DEVIATION 1.4 • n=34 Participants • Data were obtained on 34 of the 36 participants.
|
|
Digits backwards
|
8.3 Number of correct trials
STANDARD_DEVIATION 2.7 • n=12 Participants • Data were obtained for 33 of the 36 participants.
|
9.5 Number of correct trials
STANDARD_DEVIATION 2.5 • n=11 Participants • Data were obtained for 33 of the 36 participants.
|
11.3 Number of correct trials
STANDARD_DEVIATION 2.5 • n=10 Participants • Data were obtained for 33 of the 36 participants.
|
9.6 Number of correct trials
STANDARD_DEVIATION 2.8 • n=33 Participants • Data were obtained for 33 of the 36 participants.
|
PRIMARY outcome
Timeframe: Week 2 and Week 3Population: Data was missing for two participants.
A modified Cognitive Therapy Awareness Scale (CTAS) was used to assess delayed memory for cognitive therapy content from the computerized CBT. Higher scores indicate better memory for CBT skills. Scores range from 0 to 40.
Outcome measures
| Measure |
250 mg DCS
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=10 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
Recall of Cognitive Therapy Content
Week 2
|
25.4 Number of correct units of information
Standard Deviation 2.9
|
26.8 Number of correct units of information
Standard Deviation 4.0
|
24.7 Number of correct units of information
Standard Deviation 4.0
|
|
Recall of Cognitive Therapy Content
Week 3
|
28.2 Number of correct units of information
Standard Deviation 4.2
|
29.7 Number of correct units of information
Standard Deviation 3.9
|
28.7 Number of correct units of information
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: Week 2 and Week 31 Week Delayed Recall of a Threat-Related Story. Scores can range from 0 to 74, with higher scores reflect greater memory for story items.
Outcome measures
| Measure |
250 mg DCS
n=13 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=11 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
1 Week Delayed Recall of Emotional Story Items
Week 2
|
13.5 units on a scale
Standard Deviation 10.4
|
21.3 units on a scale
Standard Deviation 8.0
|
16.1 units on a scale
Standard Deviation 9.5
|
|
1 Week Delayed Recall of Emotional Story Items
Week 3
|
25.0 units on a scale
Standard Deviation 13.9
|
37.3 units on a scale
Standard Deviation 12.3
|
26.4 units on a scale
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: Week 2 and Week 3Higher scores reflect greater recall of Wechsler Memory Scale (WMS) Story B content assessed one week after last rehearsal. Possible scores range from 0 to 25.
Outcome measures
| Measure |
250 mg DCS
n=13 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=11 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
1 Week Delayed Recall Logical Memory
Week 2
|
1.8 units on a scale
Standard Deviation 2.3
|
4.4 units on a scale
Standard Deviation 4.3
|
5.0 units on a scale
Standard Deviation 3.8
|
|
1 Week Delayed Recall Logical Memory
Week 3
|
9.5 units on a scale
Standard Deviation 5.0
|
12.8 units on a scale
Standard Deviation 5.5
|
13.6 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3Immediate Story Recall from the Wechsler Memory Scale Story B. Higher scores reflect greater recall of the story material from the previous week. Possible scores range from 0 to 25.
Outcome measures
| Measure |
250 mg DCS
n=13 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=11 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
Logical Memory Immediate Recall
Week 1
|
14.8 Number of story units recalled
Standard Deviation 4.3
|
17.1 Number of story units recalled
Standard Deviation 2.8
|
16.2 Number of story units recalled
Standard Deviation 4.7
|
|
Logical Memory Immediate Recall
Week 2
|
17.7 Number of story units recalled
Standard Deviation 3.4
|
17.8 Number of story units recalled
Standard Deviation 4.1
|
18.2 Number of story units recalled
Standard Deviation 2.9
|
|
Logical Memory Immediate Recall
Week 3
|
18.5 Number of story units recalled
Standard Deviation 3.0
|
21.5 Number of story units recalled
Standard Deviation 2.2
|
21.2 Number of story units recalled
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3Population: Data is missing for two participants.
The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The patient's free recall of the list is recorded. The same procedure is repeated for two more trials. The total recall score for the third trial was used as the recorded score and ranged from a minimum of zero to a maximum of 12 correct answers.
Outcome measures
| Measure |
250 mg DCS
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=10 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
Immediate Memory Measured by the Hopkins Verbal Learning Task
Week 1
|
7.8 Number of words recalled
Standard Deviation 1.7
|
9.9 Number of words recalled
Standard Deviation 1.2
|
9.4 Number of words recalled
Standard Deviation 1.5
|
|
Immediate Memory Measured by the Hopkins Verbal Learning Task
Week 2
|
8.7 Number of words recalled
Standard Deviation 1.6
|
9.7 Number of words recalled
Standard Deviation 1.3
|
9.6 Number of words recalled
Standard Deviation 1.3
|
|
Immediate Memory Measured by the Hopkins Verbal Learning Task
Week 3
|
8.8 Number of words recalled
Standard Deviation 1.8
|
10.1 Number of words recalled
Standard Deviation 1.1
|
9.4 Number of words recalled
Standard Deviation 2.2
|
|
Immediate Memory Measured by the Hopkins Verbal Learning Task
Baseline
|
8.5 Number of words recalled
Standard Deviation 1.3
|
9.6 Number of words recalled
Standard Deviation 1.1
|
9.6 Number of words recalled
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3Immediate recall score of items from the Emotional Story presentation. Scores can range from 0 to 74, with higher scores reflect greater memory for story items.
Outcome measures
| Measure |
250 mg DCS
n=13 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=11 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
Immediate Recall of Emotional Story Items
Week 1
|
22.4 Number of story units recalled
Standard Deviation 11.9
|
35.2 Number of story units recalled
Standard Deviation 9.4
|
32.2 Number of story units recalled
Standard Deviation 13.3
|
|
Immediate Recall of Emotional Story Items
Week 2
|
34.4 Number of story units recalled
Standard Deviation 12.6
|
46.8 Number of story units recalled
Standard Deviation 10.9
|
35.5 Number of story units recalled
Standard Deviation 11.0
|
|
Immediate Recall of Emotional Story Items
Week 3
|
38.4 Number of story units recalled
Standard Deviation 12.9
|
49.9 Number of story units recalled
Standard Deviation 12.4
|
43.4 Number of story units recalled
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Week 2 and Week 3Population: Data is missing for one participant.
This measure assesses the self-reported use of skills from cognitive therapy. Scores can range from 8 to 40, and higher scores indicate greater use.
Outcome measures
| Measure |
250 mg DCS
n=11 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=10 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
Skills of Cognitive Therapy
Week 2
|
23.3 units on a scale
Standard Deviation 6.4
|
20.5 units on a scale
Standard Deviation 5.5
|
24.8 units on a scale
Standard Deviation 5.6
|
|
Skills of Cognitive Therapy
Week 3
|
26.4 units on a scale
Standard Deviation 8.5
|
24.3 units on a scale
Standard Deviation 7.2
|
25.7 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3Population: Data is missing for two participants.
The examiner reads a list of digits and asks that each digit be read backwards. The score is the total number of trials completed correctly; scores range from 0 to 16. Higher scores indicate better performance.
Outcome measures
| Measure |
250 mg DCS
n=12 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=11 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=10 Participants
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
Digits Backward
Week 3
|
9.6 Number of correct trials
Standard Deviation 2.7
|
11.4 Number of correct trials
Standard Deviation 2.2
|
11.7 Number of correct trials
Standard Deviation 2.4
|
|
Digits Backward
Baseline
|
8.3 Number of correct trials
Standard Deviation 2.7
|
9.5 Number of correct trials
Standard Deviation 2.5
|
11.3 Number of correct trials
Standard Deviation 2.5
|
|
Digits Backward
Week 1
|
9.25 Number of correct trials
Standard Deviation 2.8
|
10.4 Number of correct trials
Standard Deviation 2.2
|
12.2 Number of correct trials
Standard Deviation 2.2
|
|
Digits Backward
Week 2
|
10.0 Number of correct trials
Standard Deviation 3.2
|
11.3 Number of correct trials
Standard Deviation 2.0
|
12.1 Number of correct trials
Standard Deviation 1.7
|
Adverse Events
250 mg DCS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
100 mg Modafinil
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
250 mg DCS
n=13 participants at risk
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
250 mg DCS: Drug
|
100 mg Modafinil
n=12 participants at risk
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
100 mg Modafinil: Drug
|
Placebo
n=11 participants at risk
Randomized drug intervention was administered on two weekly sessions following baseline evaluation
Placebo: Drug
|
|---|---|---|---|
|
General disorders
Increased Energy/Concentration
|
15.4%
2/13 • Number of events 3 • Adverse events for the visits on which study drugs were administered were assessed at the end of that session and (retrospectively) one week later for events occurring within several hours after that session (at Weeks 2 and 3, and retrospectively at 4). Serious adverse events were reported for the 4-week trial period as a whole.
Adverse events were assessed by open query
|
33.3%
4/12 • Number of events 5 • Adverse events for the visits on which study drugs were administered were assessed at the end of that session and (retrospectively) one week later for events occurring within several hours after that session (at Weeks 2 and 3, and retrospectively at 4). Serious adverse events were reported for the 4-week trial period as a whole.
Adverse events were assessed by open query
|
18.2%
2/11 • Number of events 3 • Adverse events for the visits on which study drugs were administered were assessed at the end of that session and (retrospectively) one week later for events occurring within several hours after that session (at Weeks 2 and 3, and retrospectively at 4). Serious adverse events were reported for the 4-week trial period as a whole.
Adverse events were assessed by open query
|
|
General disorders
Fatigue/Low Motivation
|
15.4%
2/13 • Number of events 3 • Adverse events for the visits on which study drugs were administered were assessed at the end of that session and (retrospectively) one week later for events occurring within several hours after that session (at Weeks 2 and 3, and retrospectively at 4). Serious adverse events were reported for the 4-week trial period as a whole.
Adverse events were assessed by open query
|
25.0%
3/12 • Number of events 3 • Adverse events for the visits on which study drugs were administered were assessed at the end of that session and (retrospectively) one week later for events occurring within several hours after that session (at Weeks 2 and 3, and retrospectively at 4). Serious adverse events were reported for the 4-week trial period as a whole.
Adverse events were assessed by open query
|
45.5%
5/11 • Number of events 5 • Adverse events for the visits on which study drugs were administered were assessed at the end of that session and (retrospectively) one week later for events occurring within several hours after that session (at Weeks 2 and 3, and retrospectively at 4). Serious adverse events were reported for the 4-week trial period as a whole.
Adverse events were assessed by open query
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place