Trial Outcomes & Findings for Spectroscopic Imaging at 4T: A Drug Challenge Study (NCT NCT01577706)

NCT ID: NCT01577706

Last Updated: 2017-04-04

Results Overview

The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100\*(later timepoint - earlier timepoint) / earlier timepoint

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Results posted on

2017-04-04

Participant Flow

Participant milestones

Participant milestones
Measure
Dextroamphetamine, Alprazolam, Placebo Sequence
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day Placebo: single-dose, 1-day
Alprazolam, Dextroamphetamine, Placebo Sequence
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day Placebo: single-dose, 1-day
Placebo, Dextroamphetamine, Alprazolam Sequence
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day Placebo: single-dose, 1-day
First Intervention (1 Day)
STARTED
3
1
3
First Intervention (1 Day)
COMPLETED
3
1
3
First Intervention (1 Day)
NOT COMPLETED
0
0
0
Washout (at Least 1 Week)
STARTED
3
1
3
Washout (at Least 1 Week)
COMPLETED
3
1
3
Washout (at Least 1 Week)
NOT COMPLETED
0
0
0
Second Intervention (1 Day)
STARTED
3
1
3
Second Intervention (1 Day)
COMPLETED
3
1
3
Second Intervention (1 Day)
NOT COMPLETED
0
0
0
Third Intervention (1 Day)
STARTED
3
1
3
Third Intervention (1 Day)
COMPLETED
3
1
3
Third Intervention (1 Day)
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Spectroscopic Imaging at 4T: A Drug Challenge Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
28.9 years
STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Region of Enrollment
United States
7 participants
n=5 Participants

PRIMARY outcome

Timeframe: from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100\*(later timepoint - earlier timepoint) / earlier timepoint

Outcome measures

Outcome measures
Measure
Placebo
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day
Alprazolam
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t2: 45min-64min
-6.80 percent change
Interval -21.48 to 16.18
23.57 percent change
Interval -1.97 to 64.94
-12.51 percent change
Interval -21.04 to 21.22
Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t3: 45min-83min
-2.63 percent change
Interval -7.82 to 16.87
39.29 percent change
Interval 29.17 to 50.69
8.26 percent change
Interval -8.12 to 46.09
Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t4: 45min-102min
10.01 percent change
Interval -25.15 to 25.52
23.30 percent change
Interval 17.75 to 58.61
13.63 percent change
Interval -1.96 to 44.44
Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t3: 64min-83min
4.47 percent change
Interval -16.73 to 52.66
12.72 percent change
Interval 1.46 to 37.76
17.75 percent change
Interval 5.02 to 30.2
Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t3 to t4: 83min-102min
-6.32 percent change
Interval -20.28 to 32.66
-2.10 percent change
Interval -10.9 to 9.2
5.45 percent change
Interval -22.42 to 25.76
Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t4: 64min-102min
15.44 percent change
Interval -16.72 to 47.92
10.79 percent change
Interval -4.71 to 44.32
24.16 percent change
Interval -0.26 to 38.62

PRIMARY outcome

Timeframe: from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100\*(later timepoint - earlier timepoint) / earlier timepoint

Outcome measures

Outcome measures
Measure
Placebo
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day
Alprazolam
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t2: 45min-64min
-2.91 percent change
Interval -32.57 to 40.7
43.17 percent change
Interval 12.28 to 47.33
5.28 percent change
Interval -6.26 to 39.08
Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t3: 45min-83min
2.11 percent change
Interval -12.57 to 24.86
43.09 percent change
Interval 0.95 to 121.66
17.06 percent change
Interval -8.04 to 58.61
Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t4: 45min-102min
15.59 percent change
Interval -24.01 to 47.89
44.26 percent change
Interval 26.85 to 57.43
14.68 percent change
Interval -24.68 to 80.77
Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t3: 64min-83min
-0.58 percent change
Interval -31.51 to 49.01
6.57 percent change
Interval -7.83 to 35.21
13.40 percent change
Interval -1.9 to 14.04
Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t3 to t4: 83min-102min
2.66 percent change
Interval -23.72 to 99.09
3.53 percent change
Interval -30.3 to 42.9
20.19 percent change
Interval -32.47 to 47.63
Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t4: 64min-102min
5.10 percent change
Interval -21.73 to 45.14
-4.57 percent change
Interval -25.72 to 28.48
22.34 percent change
Interval 3.56 to 32.7

PRIMARY outcome

Timeframe: from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Population: One participant is missing GABA level at t4 while on Placebo, and one participant is missing GABA level at t2 while on Alprazolam.

The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100\*(later timepoint - earlier timepoint) / earlier timepoint

Outcome measures

Outcome measures
Measure
Placebo
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day
Alprazolam
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t2: 45min-64min
-10.24 percent change
Interval -30.56 to 97.99
4.38 percent change
Interval -22.54 to 60.19
6.36 percent change
Interval -9.12 to 58.23
Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t3: 45min-83min
-13.82 percent change
Interval -61.55 to -10.61
13.44 percent change
Interval -18.74 to 56.65
1.34 percent change
Interval -12.22 to 15.03
Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t4: 45min-102min
-8.77 percent change
Interval -17.82 to 7.78
58.49 percent change
Interval -56.01 to 98.58
18.24 percent change
Interval -15.13 to 31.52
Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t3: 64min-83min
-10.55 percent change
Interval -34.46 to 24.1
14.55 percent change
Interval -2.21 to 48.14
-6.70 percent change
Interval -27.3 to 15.62
Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t3 to t4: 83min-102min
3.83 percent change
Interval -4.64 to 55.05
32.81 percent change
Interval -45.86 to 44.54
7.53 percent change
Interval -20.13 to 29.78
Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t4: 64min-102min
-2.03 percent change
Interval -40.16 to 1.63
19.68 percent change
Interval -43.21 to 54.55
-20.20 percent change
Interval -26.64 to 15.38

PRIMARY outcome

Timeframe: from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100\*(later timepoint - earlier timepoint) / earlier timepoint

Outcome measures

Outcome measures
Measure
Placebo
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day
Alprazolam
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t2: 45min-64min
6.09 percent change
Interval -14.53 to 23.67
-0.51 percent change
Interval -26.89 to 22.96
39.69 percent change
Interval -12.79 to 47.24
Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t3: 45min-83min
-1.60 percent change
Interval -13.79 to 21.08
1.90 percent change
Interval -4.5 to 13.63
-10.29 percent change
Interval -21.14 to 21.33
Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t4: 45min-102min
24.54 percent change
Interval -1.31 to 59.63
21.95 percent change
Interval 5.9 to 41.0
22.35 percent change
Interval 1.0 to 56.99
Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t3: 64min-83min
2.15 percent change
Interval -20.41 to 30.46
4.64 percent change
Interval -7.82 to 37.25
-17.33 percent change
Interval -41.0 to 2.01
Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
t3 to t4: 83min-102min
21.76 percent change
Interval 15.07 to 33.23
10.78 percent change
Interval -8.66 to 33.39
36.38 percent change
Interval 19.58 to 65.32
Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t4: 64min-102min
33.46 percent change
Interval 3.73 to 50.47
18.83 percent change
Interval 3.59 to 41.72
7.97 percent change
Interval -19.53 to 26.83

PRIMARY outcome

Timeframe: from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Population: One participant ismissing GABA level at t4 while on Dextroamphetamine

The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100\*(later timepoint - earlier timepoint) / earlier timepoint

Outcome measures

Outcome measures
Measure
Placebo
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day
Alprazolam
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t2: 45min-64min
6.55 percent change
Interval -6.15 to 44.75
2.72 percent change
Interval -9.2 to 8.24
-3.61 percent change
Interval -28.4 to 20.53
Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t3: 45min-83min
7.26 percent change
Interval 3.35 to 19.28
19.20 percent change
Interval 0.03 to 26.12
14.63 percent change
Interval -15.89 to 33.19
Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t4: 45min-102min
8.39 percent change
Interval -14.79 to 56.45
4.54 percent change
Interval -9.9 to 25.8
30.23 percent change
Interval 20.15 to 43.23
Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t3: 64min-83min
-7.13 percent change
Interval -16.64 to 10.54
16.51 percent change
Interval 7.97 to 35.51
14.95 percent change
Interval -13.8 to 33.15
Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t3 to t4: 83min-102min
2.87 percent change
Interval -17.56 to 31.88
-1.78 percent change
Interval -24.21 to 1.69
1.60 percent change
Interval -15.84 to 4.82
Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t4: 64min-102min
12.69 percent change
Interval -9.21 to 13.71
12.12 percent change
Interval -11.69 to 38.55
15.51 percent change
Interval 10.05 to 24.66

PRIMARY outcome

Timeframe: from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Population: One participant is missing GABA level at t4 while on Dextroamphetamine.

The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100\*(later timepoint - earlier timepoint) / earlier timepoint

Outcome measures

Outcome measures
Measure
Placebo
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day
Alprazolam
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t2: 45min-64min
18.63 percent change
Interval -13.56 to 32.9
-9.44 percent change
Interval -33.69 to -1.73
38.78 percent change
Interval -20.68 to 69.65
Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t3: 45min-83min
-3.97 percent change
Interval -27.05 to 21.12
3.03 percent change
Interval -19.95 to 34.72
67.41 percent change
Interval 4.27 to 106.38
Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t4: 45min-102min
-1.53 percent change
Interval -18.69 to 146.9
33.58 percent change
Interval -7.07 to 35.39
37.92 percent change
Interval -34.2 to 69.05
Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t3: 64min-83min
-9.88 percent change
Interval -23.9 to 1.5
17.08 percent change
Interval 4.36 to 37.09
21.02 percent change
Interval -23.89 to 43.86
Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t3 to t4: 83min-102min
11.46 percent change
Interval -18.7 to 178.53
-0.82 percent change
Interval -9.81 to 37.07
-5.96 percent change
Interval -20.03 to 1.13
Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t4: 64min-102min
10.15 percent change
Interval -7.73 to 64.39
35.96 percent change
Interval 5.21 to 47.5
14.20 percent change
Interval -3.22 to 37.44

PRIMARY outcome

Timeframe: from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)

Population: One participant is missing GABA level at t4 while on Dextroamphetamine. Another participant is missing GABA levels both at t2 and t4 while on Dextroamphetamine. Another participant is missing GABA levels at both t2 and t4 while on Alprazolam.

The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge. GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100\*(later timepoint - earlier timepoint) / earlier timepoint

Outcome measures

Outcome measures
Measure
Placebo
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Placebo: single-dose, 1-day
Alprazolam
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day
Dextroamphetamine
n=7 Participants
Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t2: 45min-64min
14.93 percent change
Interval -18.14 to 48.46
-1.45 percent change
Interval -19.95 to 4.29
2.09 percent change
Interval -44.68 to 40.24
Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t3: 45min-83min
21.26 percent change
Interval -29.56 to 62.94
24.29 percent change
Interval -57.06 to 49.03
-23.17 percent change
Interval -92.17 to 39.24
Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t1 to t4: 45min-102min
48.95 percent change
Interval 5.69 to 91.43
31.06 percent change
Interval -10.94 to 62.58
30.23 percent change
Interval -48.74 to 88.02
Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t3: 64min-83min
-13.91 percent change
Interval -39.87 to 21.8
-4.86 percent change
Interval -16.41 to 22.82
18.52 percent change
Interval -9.25 to 42.07
Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t3 to t4: 83min-102min
10.85 percent change
Interval 2.85 to 50.03
23.34 percent change
Interval 9.1 to 44.14
70.88 percent change
Interval 9.16 to 81.35
Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge
t2 to t4: 64min-102min
26.78 percent change
Interval -31.32 to 66.56
19.53 percent change
Interval 2.75 to 52.0
31.58 percent change
Interval -7.14 to 122.1

Adverse Events

Alprazolam

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Dextroamphetamine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. J. Eric Jensen

McLean Hospital

Phone: 617-855-3366

Results disclosure agreements

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