Trial Outcomes & Findings for An Investigation of Early Life Stress and Depression (NCT NCT01701258)
NCT ID: NCT01701258
Last Updated: 2025-05-07
Results Overview
Utilizing 11C-altropane during positron emission tomography (PET) scanning allows us to measure dopamine active transporter (DAT) binding potential. Our outcome measure is Nondisplacable Binding Potential (BPND). BPND refers to the ratio at equilibrium of specifically bound radioligand to that of nondisplaceable radioligand in tissue. \*Higher BPND scores indicate greater binding potential
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
153 participants
Primary outcome timeframe
1 hour PET scan (Session 3)
Results posted on
2025-05-07
Participant Flow
Participants were recruited at McLean Hospital (Belmont, MA) between August, 2013, and June, 2017. The study was advertised using flyers, and on a number of internet bulletin boards available to the general public. Study visits were conducted in research facilities at McLean Hospital and Massachusetts General Hospital.
In session 1, subjects had a diagnostic interview, a physical exam, provided a blood sample, and completed surveys, to determine eligibility. Those eligible were invited to participate in the other sessions. Participants did not need to complete all sessions. The order depended on facility availability and convenience for participants.
Participant milestones
| Measure |
All Participants
All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.
|
Control Group
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
Control-amisulpride (fMRI Session)
After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
|
Control-placebo (fMRI Session)
After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
|
MDD Group
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode .
|
MDD-amisulpride (fMRI Session)
After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
|
MDD-placebo (fMRI Session)
After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
|
CSA/RES
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/RES-amisulpride (fMRI Session)
After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.
|
CSA/RES-placebo (fMRI Session)
After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.
|
CSA/MDD Group
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA).
|
CSA/MDD-amisulpride (fMRI Session)
After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.
|
CSA/MDD-placebo (fMRI Session)
After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.
Many eligible CSA/MDD baseline participants did not complete this session.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment and Scheduling
STARTED
|
153
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
Eligible After Screening Visit
|
96
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
Returned for Drug+fMRI (Session 2)
|
68
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
Returned for PET (Session 3)
|
73
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
Returned for EEG (Session 4)
|
66
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
COMPLETED
|
70
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
NOT COMPLETED
|
83
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Drug+fMRI (Session 2)
STARTED
|
0
|
0
|
11
|
11
|
0
|
9
|
8
|
0
|
6
|
6
|
0
|
10
|
7
|
|
Drug+fMRI (Session 2)
Received Drug Challenge
|
0
|
0
|
11
|
11
|
0
|
9
|
8
|
0
|
6
|
6
|
0
|
10
|
7
|
|
Drug+fMRI (Session 2)
COMPLETED
|
0
|
0
|
11
|
11
|
0
|
9
|
8
|
0
|
6
|
6
|
0
|
10
|
7
|
|
Drug+fMRI (Session 2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PET (Session 3)
STARTED
|
0
|
20
|
0
|
0
|
16
|
0
|
0
|
19
|
0
|
0
|
18
|
0
|
0
|
|
PET (Session 3)
COMPLETED
|
0
|
20
|
0
|
0
|
16
|
0
|
0
|
19
|
0
|
0
|
18
|
0
|
0
|
|
PET (Session 3)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
EEG (Session 4)
STARTED
|
0
|
19
|
0
|
0
|
14
|
0
|
0
|
16
|
0
|
0
|
17
|
0
|
0
|
|
EEG (Session 4)
COMPLETED
|
0
|
19
|
0
|
0
|
14
|
0
|
0
|
16
|
0
|
0
|
17
|
0
|
0
|
|
EEG (Session 4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
All Participants
All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.
|
Control Group
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
Control-amisulpride (fMRI Session)
After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
|
Control-placebo (fMRI Session)
After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
|
MDD Group
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode .
|
MDD-amisulpride (fMRI Session)
After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
|
MDD-placebo (fMRI Session)
After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
|
CSA/RES
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/RES-amisulpride (fMRI Session)
After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.
|
CSA/RES-placebo (fMRI Session)
After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.
|
CSA/MDD Group
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA).
|
CSA/MDD-amisulpride (fMRI Session)
After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.
|
CSA/MDD-placebo (fMRI Session)
After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.
Many eligible CSA/MDD baseline participants did not complete this session.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Assessment and Scheduling
Found to be Ineligible
|
57
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
Lost to Follow-up
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
Withdrawal by Subject
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Assessment and Scheduling
Investigator Terminated
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
An Investigation of Early Life Stress and Depression
Baseline characteristics by cohort
| Measure |
Control Group
n=26 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
MDD Group
n=17 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
|
CSA/RES Group
n=24 Participants
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/MDD Group
n=29 Participants
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
96 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
22.44 years
STANDARD_DEVIATION 6.64 • n=93 Participants
|
27.19 years
STANDARD_DEVIATION 5.99 • n=4 Participants
|
25.61 years
STANDARD_DEVIATION 4.94 • n=27 Participants
|
29.95 years
STANDARD_DEVIATION 6.91 • n=483 Participants
|
26.63 years
STANDARD_DEVIATION 6.08 • n=36 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
96 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
56 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
96 Participants
n=36 Participants
|
|
BDI II
|
1.68 units on a scale
STANDARD_DEVIATION 2.79 • n=93 Participants
|
27.23 units on a scale
STANDARD_DEVIATION 8.44 • n=4 Participants
|
3.83 units on a scale
STANDARD_DEVIATION 5.77 • n=27 Participants
|
31.49 units on a scale
STANDARD_DEVIATION 9.05 • n=483 Participants
|
15.95 units on a scale
STANDARD_DEVIATION 15.14 • n=36 Participants
|
|
MASQ total
|
93.04 units on a scale
STANDARD_DEVIATION 16.27 • n=93 Participants
|
167.86 units on a scale
STANDARD_DEVIATION 22.60 • n=4 Participants
|
101.82 units on a scale
STANDARD_DEVIATION 26.19 • n=27 Participants
|
180.57 units on a scale
STANDARD_DEVIATION 21.89 • n=483 Participants
|
135.42 units on a scale
STANDARD_DEVIATION 44.65 • n=36 Participants
|
PRIMARY outcome
Timeframe: 1 hour PET scan (Session 3)Utilizing 11C-altropane during positron emission tomography (PET) scanning allows us to measure dopamine active transporter (DAT) binding potential. Our outcome measure is Nondisplacable Binding Potential (BPND). BPND refers to the ratio at equilibrium of specifically bound radioligand to that of nondisplaceable radioligand in tissue. \*Higher BPND scores indicate greater binding potential
Outcome measures
| Measure |
Control Group
n=20 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
MDD Group
n=16 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
|
CSA/RES Group
n=19 Participants
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/MDD Group
n=18 Participants
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
|
MDD-amisulpride
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
MDD-placebo
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
Control-amisulpride
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
Control-placebo
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
|---|---|---|---|---|---|---|---|---|
|
Dopamine Active Transporter Binding Potential
Putamen
|
3.361 Ratio
Standard Error 0.120
|
3.359 Ratio
Standard Error 0.134
|
3.241 Ratio
Standard Error 0.125
|
3.318 Ratio
Standard Error 0.131
|
—
|
—
|
—
|
—
|
|
Dopamine Active Transporter Binding Potential
Caudate
|
3.191 Ratio
Standard Error 0.124
|
3.161 Ratio
Standard Error 0.139
|
3.175 Ratio
Standard Error 0.130
|
3.216 Ratio
Standard Error 0.136
|
—
|
—
|
—
|
—
|
|
Dopamine Active Transporter Binding Potential
Accumbens
|
2.159 Ratio
Standard Error 0.109
|
2.103 Ratio
Standard Error 0.122
|
2.103 Ratio
Standard Error 0.122
|
2.149 Ratio
Standard Error 0.119
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 hour EEG Session (Session 4)The participant's performance on the Probabilistic Reward Task (PRT) was assessed both before and after an acute stressor. The PRT is a behavioral task that measures an individual's ability to learn from rewarding stimuli and incorporate this learning into their response style (response bias). The acute stressor was the Maastricht Acute Stress Test (MAST). The score obtained is a ratio of the number of times participants correctly choose the high reward stimuli versus the low rewarding stimuli. Response bias scores range between -1 and +1. Higher response bias scores indicate a stronger response bias toward high reward stimuli. A negative response bias indicates a stronger bias toward low reward stimuli.
Outcome measures
| Measure |
Control Group
n=19 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
MDD Group
n=14 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
|
CSA/RES Group
n=16 Participants
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/MDD Group
n=17 Participants
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
|
MDD-amisulpride
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
MDD-placebo
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
Control-amisulpride
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
Control-placebo
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
|---|---|---|---|---|---|---|---|---|
|
The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress
PRT Block1: Before MAST
|
0.028 Ratio (Response Bias Score)
Standard Deviation 0.035
|
0.117 Ratio (Response Bias Score)
Standard Deviation 0.045
|
0.092 Ratio (Response Bias Score)
Standard Deviation 0.043
|
0.167 Ratio (Response Bias Score)
Standard Deviation 0.070
|
—
|
—
|
—
|
—
|
|
The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress
PRT Block2: Before MAST
|
0.124 Ratio (Response Bias Score)
Standard Deviation 0.046
|
0.155 Ratio (Response Bias Score)
Standard Deviation 0.048
|
0.130 Ratio (Response Bias Score)
Standard Deviation 0.082
|
0.168 Ratio (Response Bias Score)
Standard Deviation 0.102
|
—
|
—
|
—
|
—
|
|
The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress
PRT Block1: After MAST
|
0.128 Ratio (Response Bias Score)
Standard Deviation 0.026
|
0.078 Ratio (Response Bias Score)
Standard Deviation 0.055
|
0.079 Ratio (Response Bias Score)
Standard Deviation 0.042
|
0.048 Ratio (Response Bias Score)
Standard Deviation 0.042
|
—
|
—
|
—
|
—
|
|
The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress
PRT Block2: After MAST
|
0.245 Ratio (Response Bias Score)
Standard Deviation 0.041
|
0.128 Ratio (Response Bias Score)
Standard Deviation 0.035
|
0.143 Ratio (Response Bias Score)
Standard Deviation 0.052
|
0.127 Ratio (Response Bias Score)
Standard Deviation 0.050
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 hour EEG Session (Session 4)EEG was recorded during the probabilistic reward task (the PRT task). Participants completed the Probabilistic Reward Task (PRT) twice throughout the experiment, once before stress and once after stress. The stressor was the Maastricht Acute Stress Test (MAST). This statistic shows the effect that childhood sexual abuse (CSA) and diagnosis had on a reward-related positivity EEG component recorded during the PRT, before and after stress. * Higher reward positivity amplitudes indicate a stronger neural response to reward and lower amplitudes indicate a lower neural response to rewards.
Outcome measures
| Measure |
Control Group
n=19 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
MDD Group
n=14 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
|
CSA/RES Group
n=16 Participants
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/MDD Group
n=17 Participants
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
|
MDD-amisulpride
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
MDD-placebo
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
Control-amisulpride
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
Control-placebo
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
|---|---|---|---|---|---|---|---|---|
|
The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress
Pre MAST
|
2.71 amplitude (microvolts)
Standard Error 0.86
|
4.75 amplitude (microvolts)
Standard Error 1.15
|
2.16 amplitude (microvolts)
Standard Error 0.92
|
4.15 amplitude (microvolts)
Standard Error 0.96
|
—
|
—
|
—
|
—
|
|
The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress
Post MAST
|
2.06 amplitude (microvolts)
Standard Error 0.91
|
4.99 amplitude (microvolts)
Standard Error 1.22
|
2.30 amplitude (microvolts)
Standard Error 0.98
|
3.90 amplitude (microvolts)
Standard Error 1.01
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 hour EEG Session (Session 4)This statistic shows the impact of the stress manipulation on the participant's salivary cortisol output. Saliva samples were collected at 5 distinct time points throughout the study session. The first saliva sample (Cort 1) was collected when the participant began the eeg session. The second (Cort 2)was taken at the end of the acute stressor. The third (Cort 3) was taken approximately fifteen minutes after the second. The fourth (Cort 4) was taken approximately ten minutes after the third. The fifth (Cort 5) was taken approximately 40 minutes after the fourth.
Outcome measures
| Measure |
Control Group
n=19 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
MDD Group
n=14 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
|
CSA/RES Group
n=16 Participants
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/MDD Group
n=17 Participants
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
|
MDD-amisulpride
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
MDD-placebo
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
Control-amisulpride
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
Control-placebo
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
|---|---|---|---|---|---|---|---|---|
|
Cortisol Output in Response to a Stress Manipulation
Cort1
|
9.80 ng/ml
Standard Error 1.27
|
12.53 ng/ml
Standard Error 2.11
|
10.15 ng/ml
Standard Error 2.27
|
14.19 ng/ml
Standard Error 1.51
|
—
|
—
|
—
|
—
|
|
Cortisol Output in Response to a Stress Manipulation
Cort2
|
9.11 ng/ml
Standard Error 2.44
|
12.28 ng/ml
Standard Error 1.70
|
9.51 ng/ml
Standard Error 1.89
|
8.63 ng/ml
Standard Error 0.95
|
—
|
—
|
—
|
—
|
|
Cortisol Output in Response to a Stress Manipulation
Cort3
|
15.55 ng/ml
Standard Error 4.91
|
15.23 ng/ml
Standard Error 1.65
|
10.75 ng/ml
Standard Error 2.19
|
14.31 ng/ml
Standard Error 2.15
|
—
|
—
|
—
|
—
|
|
Cortisol Output in Response to a Stress Manipulation
Cort4
|
12.89 ng/ml
Standard Error 4.07
|
16.30 ng/ml
Standard Error 3.24
|
8.99 ng/ml
Standard Error 1.75
|
14.22 ng/ml
Standard Error 2.74
|
—
|
—
|
—
|
—
|
|
Cortisol Output in Response to a Stress Manipulation
Cort5
|
7.07 ng/ml
Standard Error 1.80
|
10.34 ng/ml
Standard Error 1.15
|
7.41 ng/ml
Standard Error 1.36
|
11.01 ng/ml
Standard Error 2.15
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 hour Drug & fMRI Session (Session 2)This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward cues during the monetary incentive delay task (MID). Striatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation.
Outcome measures
| Measure |
Control Group
n=10 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
MDD Group
n=7 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
|
CSA/RES Group
n=6 Participants
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/MDD Group
n=6 Participants
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
|
MDD-amisulpride
n=9 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
MDD-placebo
n=8 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
Control-amisulpride
n=11 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
Control-placebo
n=11 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
|---|---|---|---|---|---|---|---|---|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues
Putamen Response to Neutral Cues
|
.550 beta weight (slope)
Standard Error .175
|
.357 beta weight (slope)
Standard Error .168
|
.493 beta weight (slope)
Standard Error .181
|
.240 beta weight (slope)
Standard Error .181
|
.384 beta weight (slope)
Standard Error .148
|
.621 beta weight (slope)
Standard Error .157
|
.455 beta weight (slope)
Standard Error .134
|
.518 beta weight (slope)
Standard Error .134
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues
Accumbens Response to Neutral Cues
|
.385 beta weight (slope)
Standard Error .173
|
.040 beta weight (slope)
Standard Error .207
|
-.123 beta weight (slope)
Standard Error .224
|
-.381 beta weight (slope)
Standard Error .224
|
-.111 beta weight (slope)
Standard Error .183
|
.140 beta weight (slope)
Standard Error .194
|
.016 beta weight (slope)
Standard Error .165
|
.120 beta weight (slope)
Standard Error .165
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues
Caudate Response to Reward Cues
|
.514 beta weight (slope)
Standard Error .199
|
.054 beta weight (slope)
Standard Error .238
|
.511 beta weight (slope)
Standard Error .257
|
.079 beta weight (slope)
Standard Error .257
|
.403 beta weight (slope)
Standard Error .209
|
.608 beta weight (slope)
Standard Error .222
|
.200 beta weight (slope)
Standard Error .189
|
.468 beta weight (slope)
Standard Error .189
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues
Caudate Response to Neutral Cues
|
.254 beta weight (slope)
Standard Error .161
|
-.243 beta weight (slope)
Standard Error .192
|
.050 beta weight (slope)
Standard Error .208
|
-.370 beta weight (slope)
Standard Error .208
|
.047 beta weight (slope)
Standard Error .170
|
.156 beta weight (slope)
Standard Error .180
|
.222 beta weight (slope)
Standard Error .154
|
.185 beta weight (slope)
Standard Error .154
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues
Putamen Response to Reward Cues
|
.550 beta weight (slope)
Standard Error .175
|
.468 beta weight (slope)
Standard Error .209
|
.745 beta weight (slope)
Standard Error .226
|
.419 beta weight (slope)
Standard Error .226
|
.698 beta weight (slope)
Standard Error .185
|
.814 beta weight (slope)
Standard Error .196
|
.608 beta weight (slope)
Standard Error .162
|
.663 beta weight (slope)
Standard Error .167
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues
Accumbens Response to Reward Cues
|
.692 beta weight (slope)
Standard Error .206
|
.255 beta weight (slope)
Standard Error .247
|
.679 beta weight (slope)
Standard Error .267
|
.310 beta weight (slope)
Standard Error .267
|
.351 beta weight (slope)
Standard Error .218
|
.428 beta weight (slope)
Standard Error .231
|
.401 beta weight (slope)
Standard Error .197
|
.480 beta weight (slope)
Standard Error .197
|
PRIMARY outcome
Timeframe: 3 hour Session 2 (fMRI session)This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward feedback during the monetary incentive delay task (MID). Striatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation.
Outcome measures
| Measure |
Control Group
n=10 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
MDD Group
n=7 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
|
CSA/RES Group
n=6 Participants
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/MDD Group
n=6 Participants
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
|
MDD-amisulpride
n=9 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
MDD-placebo
n=8 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
Control-amisulpride
n=11 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
Control-placebo
n=11 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
|---|---|---|---|---|---|---|---|---|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback
Putamen Response to Neutral Feedback
|
-.021 beta weight (slope)
Standard Error .201
|
-.418 beta weight (slope)
Standard Error .240
|
-.142 beta weight (slope)
Standard Error .260
|
-.276 beta weight (slope)
Standard Error .260
|
-.229 beta weight (slope)
Standard Error .221
|
-.108 beta weight (slope)
Standard Error .225
|
-.375 beta weight (slope)
Standard Error .192
|
.164 beta weight (slope)
Standard Error .192
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback
Accumbens Response to Neutral Feedback
|
.010 beta weight (slope)
Standard Error .308
|
-.332 beta weight (slope)
Standard Error .368
|
-.079 beta weight (slope)
Standard Error .398
|
-.819 beta weight (slope)
Standard Error .398
|
-.456 beta weight (slope)
Standard Error .325
|
-.039 beta weight (slope)
Standard Error .345
|
-.503 beta weight (slope)
Standard Error .294
|
.109 beta weight (slope)
Standard Error .294
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback
Caudate Response to Reward Feedback
|
-.101 beta weight (slope)
Standard Error .329
|
.040 beta weight (slope)
Standard Error .393
|
-.197 beta weight (slope)
Standard Error .425
|
-.905 beta weight (slope)
Standard Error .425
|
-.819 beta weight (slope)
Standard Error .347
|
-.773 beta weight (slope)
Standard Error .368
|
-.613 beta weight (slope)
Standard Error .314
|
-.273 beta weight (slope)
Standard Error .314
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback
Caudate Response to Neutral Feedback
|
-.233 beta weight (slope)
Standard Error .314
|
-.608 beta weight (slope)
Standard Error .376
|
-.501 beta weight (slope)
Standard Error .406
|
-.959 beta weight (slope)
Standard Error .406
|
-.865 beta weight (slope)
Standard Error .331
|
-.733 beta weight (slope)
Standard Error .352
|
-.793 beta weight (slope)
Standard Error .300
|
-.105 beta weight (slope)
Standard Error .300
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback
Putamen Response to Reward Feedback
|
-.018 beta weight (slope)
Standard Error .217
|
.063 beta weight (slope)
Standard Error .260
|
-.087 beta weight (slope)
Standard Error .281
|
-.304 beta weight (slope)
Standard Error .281
|
-.031 beta weight (slope)
Standard Error .229
|
-.357 beta weight (slope)
Standard Error .243
|
-.533 beta weight (slope)
Standard Error .207
|
-.131 beta weight (slope)
Standard Error .207
|
|
Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback
Accumbens Response to Reward Feedback
|
-.158 beta weight (slope)
Standard Error .421
|
.839 beta weight (slope)
Standard Error .503
|
-.046 beta weight (slope)
Standard Error .544
|
-.713 beta weight (slope)
Standard Error .544
|
-.554 beta weight (slope)
Standard Error .444
|
-.215 beta weight (slope)
Standard Error .471
|
.074 beta weight (slope)
Standard Error .401
|
.069 beta weight (slope)
Standard Error .401
|
PRIMARY outcome
Timeframe: 3 hour EEG Session (Session 4)This is a measure of area under the curve in relation to ground, a measure of total cortisol output, in response to acute stress. The acute stressor was the Maastricht Acute Stress Test (MAST). The area under the curve includes all 5 cortisol measures, with one measure before the stressor and the other four measures collected after the stressor. Given that the cortisol data were positively skewed, the cortisol measures were normalized via a log transformation prior to calculating the area under the curve. Area under the curve with respect to ground (AUCG) is calculated AUC\_g=(((cort2\_log + cort1\_log) \* cort\_t1\_time) / 2)+(((cort3\_log+cort2\_log)\*cort\_t2\_time)/2)+(((cort4\_log+cort3\_log)\*cort\_t3\_time)/2)+(((cort5\_log+cort4\_log)\*cort\_t4\_time)/2). Cort\_logs are the log transformed cortisol output data (ng/ml) and the cort\_times are the time spans in between each cortisol assessment.
Outcome measures
| Measure |
Control Group
n=19 Participants
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode.
|
MDD Group
n=14 Participants
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge.
|
CSA/RES Group
n=16 Participants
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES).
|
CSA/MDD Group
n=17 Participants
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA) are randomized to receive a single low-dose pharmacological challenge.
|
MDD-amisulpride
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
MDD-placebo
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
Control-amisulpride
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.
Amisulpride: single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
|
Control-placebo
Subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode are randomized to receive a placebo during the fMRI session.
Placebo: single-dose placebo capsule during the fMRI session only
|
|---|---|---|---|---|---|---|---|---|
|
The Effect of Diagnosis on Cortisol Reactivity
|
156.58 [log (ng/ml)]*min
Standard Error 10.72
|
186.78 [log (ng/ml)]*min
Standard Error 12.20
|
152.13 [log (ng/ml)]*min
Standard Error 12.20
|
179.16 [log (ng/ml)]*min
Standard Error 11.25
|
—
|
—
|
—
|
—
|
Adverse Events
All Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Baseline Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control-amisulpride (fMRI Session)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control-placebo (fMRI Session)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MDD Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MDD-amisulpride (fMRI Session)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MDD-placebo (fMRI Session)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CSA/RES
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CSA/RES-amisulpride (fMRI Session)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CSA/RES-placebo (fMRI Session)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CSA/MDD Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CSA/MDD-amisulpride (fMRI Session)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CSA/MDD-placebo (fMRI Session)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=153 participants at risk
All participants that went through the assessment (session 1) regardless if they were eligible or ineligible.
|
All Baseline Participants
n=96 participants at risk
Participants that were eligible for the study after the screening visit (session 1). These participants were invited to participate in the other study sessions.
|
Control Group
n=26 participants at risk
Control subjects without a history of child sexual abuse and without a current or past diagnosis of major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
|
Control-amisulpride (fMRI Session)
n=11 participants at risk
After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
|
Control-placebo (fMRI Session)
n=11 participants at risk
After the screening visit, eligible control subjects without a history of child sexual abuse and without a current or past diagnosis of major depression were invited to participate in the fMRI session. Those that were interested, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible baseline control participants did not complete this session.
|
MDD Group
n=17 participants at risk
Subjects without a history of child sexual abuse that are currently experiencing a major depressive episode. These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
|
MDD-amisulpride (fMRI Session)
n=9 participants at risk
After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
|
MDD-placebo (fMRI Session)
n=8 participants at risk
After the screening visit, eligible subjects without a history of child sexual abuse that are currently experiencing a major depressive episode were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible MDD baseline participants did not complete this session.
|
CSA/RES
n=24 participants at risk
Subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
|
CSA/RES-amisulpride (fMRI Session)
n=6 participants at risk
After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.
|
CSA/RES-placebo (fMRI Session)
n=6 participants at risk
After the screening visit, eligible subjects with a history of CSA but no psychopathology ("resilient group"; CSA/RES) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo during the fMRI session. This arm is specific to those that competed the fMRI session. Many eligible CSA/RES baseline participants did not complete this session.
|
CSA/MDD Group
n=29 participants at risk
Subjects experiencing a current episode of major depression (MDD) with a history of child sexual abuse (CSA). These participants were eligible after the screening session (session 1) and are accounted for regardless if they completed other study sessions.
|
CSA/MDD-amisulpride (fMRI Session)
n=10 participants at risk
After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a single low-dose pharmacological challenge, 50mg amisulpride tablet during the fMRI session.This arm is specific to those that competed the fMRI session. Many eligible CSA/MDD baseline participants did not complete this session.
|
CSA/MDD-placebo (fMRI Session)
n=7 participants at risk
After the screening visit, eligible subjects with a current episode of major depression (MDD) with a history of child sexual abuse (CSA) were invited to participate in the fMRI session. Those that were interested in participating, were randomized to receive a placebo. This arm is specific to those that competed the fMRI session.
Many eligible CSA/MDD baseline participants did not complete this session.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Other Adverse Events
|
0.00%
0/153 • 3 years, 10 months
|
0.00%
0/96 • 3 years, 10 months
|
0.00%
0/26 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/11 • 3 years, 10 months
|
0.00%
0/17 • 3 years, 10 months
|
0.00%
0/9 • 3 years, 10 months
|
0.00%
0/8 • 3 years, 10 months
|
0.00%
0/24 • 3 years, 10 months
|
0.00%
0/6 • 3 years, 10 months
|
0.00%
0/6 • 3 years, 10 months
|
0.00%
0/29 • 3 years, 10 months
|
0.00%
0/10 • 3 years, 10 months
|
0.00%
0/7 • 3 years, 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place