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The Effects of Dopamine on Reward Processing

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ClinicalTrials.gov Identifier: NCT01253421
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : January 18, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Diego A. Pizzagalli, Mclean Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder (MDD)
Interventions: Drug: amisulpride
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at McLean Hospital (Belmont, MA) and Massachusetts General Hospital (MGH; Boston, MA) between February, 2012, and September, 2015. 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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
An assessment visit was conducted prior to the drug-challenge visit. Subjects had a diagnostic interview (SCID) and preliminary physical exam, provided a blood sample for lab tests, and completed surveys, to determine eligibility. Those meeting eligibility criteria were scheduled for a drug+scanning visit where randomization occurred.

Reporting Groups
  Description
All Participants Prior to Randomization All Participants went through Assessment, prior to randomization.
MDD-amisulpride Subjects experiencing a current episode of major depression who are randomized to receive amisulpride
MDD-placebo Subjects experiencing a current episode of major depression who are randomized to receive placebo
HC-amisulpride Subjects having no history of mental disorder who are randomized to receive amisulpride
HC-placebo Subjects having no history of mental disorder who are randomized to receive placebo

Participant Flow for 2 periods

Period 1:   Assessment and Scheduling
    All Participants Prior to Randomization   MDD-amisulpride   MDD-placebo   HC-amisulpride   HC-placebo
STARTED [1]   159   0 [2]   0 [2]   0 [2]   0 [2] 
Eligible After Screening Visit   85   0   0   0   0 
Returned for Drug+Scanning Visit [3]   60   0   0   0   0 
COMPLETED [4]   60   0   0   0   0 
NOT COMPLETED   99   0   0   0   0 
Found to be Ineligible                74                0                0                0                0 
Lost to Follow-up                17                0                0                0                0 
Withdrawal by Subject                7                0                0                0                0 
Physician Decision                1                0                0                0                0 
[1] Enrolled for screening visit
[2] Arm has no participants until randomization.
[3] This milestone accounts for participants who were lost to follow up or withdrew for other reasons.
[4] These 60 participants enter Period 2.

Period 2:   Drug+Scanning Visit
    All Participants Prior to Randomization   MDD-amisulpride   MDD-placebo   HC-amisulpride   HC-placebo
STARTED [1]   0 [2]   15   14   16   15 
Received Drug Challenge   0   15   14   16   15 
COMPLETED   0   15   14   16   14 
NOT COMPLETED   0   0   0   0   1 
Physician Decision                0                0                0                0                1 
[1] At the start of this period, all 60 active participants are randomized to a drug-X-condition arm
[2] Arm has no participants once randomization has occurred.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MDD-amisulpride Subjects experiencing a current episode of major depression who received amisulpride
MDD-placebo Subjects experiencing a current episode of major depression who received placebo
HC-amisulpride Subjects having no history of mental disorder who received amisulpride
HC-placebo Subjects having no history of mental disorder who received placebo
Total Total of all reporting groups

Baseline Measures
   MDD-amisulpride   MDD-placebo   HC-amisulpride   HC-placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   14   16   14   59 
Age 
[Units: Years]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   27.20  (8.6)   25.8  (5.35)   25.3  (25.3)   24.7  (24.7)   26  (6.79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed   15   14   16   14   59 
Female      12  80.0%      6  42.9%      11  68.8%      9  64.3%      38  64.4% 
Male      3  20.0%      8  57.1%      5  31.3%      5  35.7%      21  35.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Participants Analyzed   15   14   16   14   59 
Hispanic or Latino      3  20.0%      1   7.1%      3  18.8%      0   0.0%      7  11.9% 
Not Hispanic or Latino      12  80.0%      13  92.9%      12  75.0%      14 100.0%      51  86.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   6.3%      0   0.0%      1   1.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Participants Analyzed   15   14   16   14   59 
American Indian or Alaska Native      0   0.0%      0   0.0%      1   6.3%      0   0.0%      1   1.7% 
Asian      2  13.3%      2  14.3%      0   0.0%      5  35.7%      9  15.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   6.7%      2  14.3%      3  18.8%      3  21.4%      9  15.3% 
White      11  73.3%      9  64.3%      10  62.5%      6  42.9%      36  61.0% 
More than one race      1   6.7%      1   7.1%      1   6.3%      0   0.0%      3   5.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   6.3%      0   0.0%      1   1.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States           
Participants Analyzed   15   14   16   14   59 
United States   15   14   16   14   59 
Educ-yrs [1] 
[Units: Years]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   15.6  (2.06)   16.6  (2.90)   16.2  (2.13)   16.5  (1.52)   16.2  (2.18) 
[1] Years of Education
Menstrual phase [1] [2] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   12   6   11   9   38 
Follicular      1   8.3%      2  33.3%      6  54.5%      3  33.3%      12  31.6% 
Luteal      4  33.3%      1  16.7%      1   9.1%      3  33.3%      9  23.7% 
Unknown      7  58.3%      3  50.0%      4  36.4%      3  33.3%      17  44.7% 
[1] Menstrual phase when scanned (females only)
[2] Percent among females only
HRSD [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   14   14   13   13   54 
   16.4  (3.37)   18.4  (5.09)   1.0  (1.58)   0.5  (0.66)   9.37  (8.997) 
[1] Hamilton Rating Scale for Depression (HRSD), 17 item. Range: 0 (no symptoms) to 52 (maximum symptom severity) Clinical categories for total score: 0-7: absent; 8-13: mild; 14-19: moderate; 20-25: severe; 26-52: very severe.
[2] 5 missing values
MDD SCID rating [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   2.9  (.27)   2.9  (.27)   1  (0)   1  (0)   1.93  (.99) 
[1] Diagnostic rating of Major Depressive Disorder (MDD): 3=Meets Criteria; 2=Subthreshold; 1=Absent
# MDEs [1] [2] 
[Units: Episodes]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   0   0   29 
   2.75  (2.667)   4.79  (3.490)         3.74  (3.230) 
[1] Number of discrete major depressive episodes (MDE).
[2] Applies to MDD subjects only
Length_MDE [1] [2] 
[Units: Months]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   0   0   29 
   20.50  (16.53)   14.00  (18.982)         16.17  (17.771) 
[1] Length of the current major depressive episode (months)
[2] Statistics include MDD subjects only
Patients with comorbid anxiety disorder [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   15   14   16   14   59 
Has comorbid Anxiety Disorder      3  20.0%      6  42.9%      0   0.0%      0   0.0%      9  15.3% 
No comorbid Anxiety Disorder      9  60.0%      8  57.1%      16 100.0%      14 100.0%      47  79.7% 
Unknown      3  20.0%      0   0.0%      0   0.0%      0   0.0%      3   5.1% 
[1] Number of subjects with current comorbid Anxiety Disorders
Patients with past anxiety disorder [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   15   14   16   14   59 
Yes      3  20.0%      6  42.9%      0   0.0%      0   0.0%      9  15.3% 
No      9  60.0%      8  57.1%      16 100.0%      14 100.0%      47  79.7% 
Unknown      3  20.0%      0   0.0%      0   0.0%      0   0.0%      3   5.1% 
[1] Number of subjects with past comorbid Anxiety Disorders
TCI Total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   87.97  (13.992)   94.2  (17.78)   103.9  (13.99)   105.9  (14.53)   97.97  (16.417) 
[1]

Total score on the Novelty-Seeking (NS) subset of the Temperament and Character Inventory (TCI). The NS subset consists of 35 items from the full 240-item TCI survey.

ITEMS: statements people might use to describe their attitudes, opinions, interests, and other personal feelings. Item responses are on a 5-point scale of 1 (definitely false) to 5 (definitely true); Range: 35-175.

Higher scores indicate higher Novelty-Seeking temperament.

TCI NS-1 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   27.760  (5.4779)   29.385  (5.3000)   34.200  (5.7595)   35.857  (5.8159)   31.814  (6.4070) 
[1] TCI NS subscale 1 – “Exploratory excitability v stoic rigidity”; 10 items, Range: 10-50; Higher scores indicate higher degree of exploratory excitability
TCI NS-2 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   19.60  (4.137)   20.85  (6.053)   22.93  (4.698)   22.79  (5.860)   21.54  (5.258) 
[1] TCI NS subscale 2 – “Impulsiveness v reflection”; 9 items, Range: 9-45; Higher scores indicate higher degree of impulsiveness
TCI NS-3 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   23.873  (6.9297)   25.231  (8.8615)   26.667  (5.5891)   26.571  (4.3273)   25.581  (6.5084) 
[1] TCI NS subscale 3 – “Extravagance v reserve” ; 9 items, Range: 9-45; Higher scores indicate higher degree of extravagance.
TCI NS-4 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   16.73  (3.973)   18.77  (3.468)   20.07  (5.311)   20.64  (4.551)   19.04  (4.555) 
[1] TCI NS subscale 4 – “Disorderliness v regimentation” ; 7 items, Range: 7-35; Higher scores indicate higher degree of disorderliness.
BIS attention-1 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   10.393  (2.3053)   9.929  (1.9400)   9.620  (1.9879)   11.000  (2.3205)   10.225  (2.1500) 
[1] Attention subscale (first order) of the Barratt Impulsiveness Scale (BIS); 5 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 5-20, higher scores indicate less stable attention
BIS cognitive instability [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   5.143  (1.7913)   5.536  (1.9852)   4.467  (1.1255)   5.857  (1.5619)   5.237  (1.6800) 
[1] Cognitive Instability subscale (first order) of the BIS; 3 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 3-12, higher scores indicate less stable cognition
BIS motor-1 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   12.714  (2.6144)   12.786  (2.9136)   12.133  (2.2636)   12.071  (2.9733)   12.421  (2.6454) 
[1] Motor subscale (first order) of the BIS; 7 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 7-28, higher scores indicate greater motor impulsivity
BIS perseverance [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   6.643  (1.5984)   6.857  (1.6104)   6.847  (1.4426)   7.693  (1.9408)   7.007  (1.6593) 
[1] Perseverance subscale (first order) of the BIS; 4 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 4-16, higher scores indicate more perseveration
BIS self control [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   11.071  (3.2455)   10.429  (3.0813)   11.067  (3.6345)   12.357  (3.2959)   11.228  (3.3113) 
[1] Self-control subscale (first order) of the BIS; 6 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); Range 6-24, higher scores indicate less self-control
BIS cognitive complexity [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   9.786  (2.0069)   10.161  (2.9509)   9.933  (2.3442)   10.554  (2.4143)   10.105  (2.4016) 
[1] Cognitive Complexity subscale (first order) of the BIS; 5 items, item responses are on a scale from 1 (not impulsive) to 4 (very impulsive); range 5-20, higher scores indicate greater difficulty with complexity
BIS Attention-2 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   15.536  (3.6187)   15.464  (2.7767)   14.087  (2.8332)   16.857  (3.2548)   15.461  (3.2078) 
[1] Attentional Impulsivity subscale (second order) of the BIS; Sum of the Attention-1 and Cognitive Instability subscales; Range 8-32, higher scores indicate less ability to control attention
BIS Motor-2 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   19.357  (3.2959)   19.643  (3.5865)   18.980  (2.8016)   19.764  (3.7056)   19.428  (3.2791) 
[1] Motor impulsivity subscale (second order) of the BIS; Sum of the Motor-1 and Perseverance subscales; Range 11-44, higher scores indicate more impulsive movement
BIS Non-planning-2 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   20.857  (4.1668)   20.589  (5.2638)   21.000  (5.7446)   22.911  (4.1459)   21.333  (4.8528) 
[1] Non-planning subscale (second order) of the BIS; Sum of the Self-control and Cognitive Complexity subscales; Range 11-44, higher scores indicate less ability to guide according to a plan
MASQ total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   173.727  (14.2367)   174.077  (18.5448)   92.350  (16.0618)   88.571  (12.4389)   131.476  (44.6597) 
[1]

Mood and Anxiety Symptom Questionnaire (MASQ), short form. Measures the severity of anxiety and depressive symptoms.

62 items, rating of how much you have experienced certain feelings, emotions, or behaviors in the past week; item responses are on a 5-point scale from 1 (not at all) to 5 (extremely).

Range: 62-310; higher scores indicates more severe symptoms.

MASQ GDA [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   21.800  (6.2244)   23.385  (6.7520)   14.200  (3.3209)   12.071  (1.9793)   17.772  (6.8060) 
[1] General Distress-Anxiety (GDA) subscale of the MASQ. 11 items on a scale of 1 to 5. Range: 11-55, higher scores indicate greater severity of anxiety symptoms.
MASQ GDD [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   41.960  (7.7346)   39.538  (7.2872)   14.533  (3.6029)   14.214  (2.9136)   27.375  (14.5034) 
[1] General Distress-Depression (GDD) subscale of the MASQ. 12 items on a scale of 1 to 5. Range: 12-60, higher scores indicate greater severity of depressive symptoms.
MASQ AA [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   21.880  (2.9644)   23.385  (4.4260)   19.417  (3.3643)   17.643  (1.1507)   20.534  (3.7852) 
[1] Anxious Arousal (AA) subscale of the MASQ; 17 items on a scale of 1 to 5; Range: 17-85, higher scores indicate greater severity of anxious arousal symptoms.
MASQ AD [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   88.087  (9.1143)   87.769  (6.9180)   44.200  (8.4448)   44.643  (9.6764)   65.795  (23.5064) 
[1] Anhedonic Depression (AD) subscale of the MASQ; 22 items on a scale of 1 to 5; Range: 22-110, higher scores indicate greater severity of anhedonic symptoms.
RSES_Total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   26.36  (4.802)   26.36  (5.988)   14.14  (3.891)   14.33  (4.633)   21.86  (7.651) 
[1]

Rosenberg Self Esteem Scale (RSES) total score. A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. All items are answered using a Likert scale ranging from strongly disagree (0) to strongly agree (3); scores on negative feelings are inverted.

Range: 0-30, higher scores indicate higher self-esteem.

Defeat Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   38.09  (6.700)   35.55  (9.720)   5.88  (3.182)   5.25  (5.392)   23.66  (17.049) 
[1] The level of defeat-related feelings the participant has felt in the past week. 16 items, rated on a scale from 0 (never) to 4 (always). Range: 0 to 64; higher scores indicate greater feelings of defeat.
BDI-II [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   24.40  (8.423)   27.91  (7.877)   1.31  (2.387)   1.51  (3.131)   13.54  (13.828) 
[1]

Beck Depression Inventory-II (BDI-II). Measures the presence and severity of 21 depressive symptoms during the past two weeks, on a scale from 0 (none, or no change) to 3 (persistent, or worsening).

Range: 0 to 63. Higher scores indicate greater symptom severity. Clinical categories for total score: 0-14: absent; 14-19: mild; 20-28: moderate; 29-63: severe.

SHPS total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   32.753  (4.6489)   32.450  (7.5103)   21.293  (5.6623)   23.714  (7.4258)   27.534  (8.0970) 
[1]

Snaith Hamilton Pleasure Scale (SHPS); assesses capacity to experience pleasure (hedonic tone).

Items: 35 statements that a person might enjoy a particular activity. Item responses are on a 4-point scale of 1 (Strongly agree) to 4 (Strongly disagree).

Range: 35-140, higher scores indicate greater anhedonia.

SHPS-low [1] 
[Units: Count of 'low' responses (1 or 2)]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   7.667  (1.3452)   6.857  (1.0995)   6.400  (1.8439)   6.571  (2.9013)   6.879  (1.9293) 
[1] Number of "low" responses (value is 1 or 2) on the SHPS. Range: 0-14; higher scores indicate better hedonic tone.
AES [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   43.45  (7.063)   42.14  (4.786)   59.53  (4.856)   60.86  (4.400)   51.63  (10.218) 
[1]

Apathy Evaluation Scale (AES), assesses apathy during the past 4 weeks. Items: 18 statements about a person feeling interest, initiative, or motivation. Item responses are on a 4-point scale of 1 (Not at all true) to 4 (Very true).

Range: 18-72, lower scores indicate greater apathy.

Current smokers [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   15   14   16   14   59 
   0   0   0   0   0 
[1] Number of current smokers per group
Past smokers [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   15   14   16   14   59 
   0   1   0   0   1 
[1] Number of subject who were smokers in the past
Current drinkers [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   15   14   16   14   59 
   4   6   5   4   19 
[1] Number of subjects who drink alcoholic beverages
Drinks in past 24hrs [1] 
[Units: Equivalent shot/can/glasses]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   0.29  (0.469)   0.46  (0.519)   0.36  (0.497)   0.29  (0.469)   0.35  (0.480) 
[1] Average number of drinks in the past 24 hours
Usual caffeine (mg) [1] 
[Units: Milligrams]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   124.35  (74.162)   176.50  (87.444)   82.93  (77.308)   64.75  (41.139)   111.05  (111.05) 
[1] Amount of caffeine consumed on a normal day in milligrams
Caffeine today (mg) [1] 
[Units: Milligrams]
Mean (Standard Deviation)
         
Participants Analyzed   15   14   16   14   59 
   81.23  (83.400)   102.88  (108.938)   32.13  (32.335)   67.23  (67.268)   69.44  (79.159) 
[1] Amount of caffeine consumed on the day of testing in milligrams


  Outcome Measures

1.  Primary:   Effect on PST Reward Learning   [ Time Frame: administered after scan ]

2.  Primary:   Effect on PST Penalty Learning   [ Time Frame: administered after scan ]

3.  Primary:   Effect on Caudate Response to Cues   [ Time Frame: Scan session ]

4.  Primary:   Effect on NAcc Response to Cues   [ Time Frame: Scan session ]

5.  Primary:   Putamen Response to Cues   [ Time Frame: Scan session ]

6.  Primary:   Effect on Caudate Response to Reward   [ Time Frame: During scan session ]

7.  Primary:   Effect on NAcc Response to Reward   [ Time Frame: During scan session ]

8.  Primary:   Effect on Putamen Response to Reward   [ Time Frame: During scan session ]

9.  Secondary:   Effect on Caudate-dACC Connectivity After Reward   [ Time Frame: During scan session ]

10.  Secondary:   Effect on NAcc-MCC Connectivity After Reward   [ Time Frame: During scan session ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The choice of a 50-mg dose of amisulpride was based on animal work showing low doses potentiate striatal dopamine release, have strong hedonic effects, and increase the incentive value of environmental cues. Higher doses may have different results.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Diego Pizzagalli, Ph.D.
Organization: McLean Hospital
phone: 617-855-4230
e-mail: dap@mclean.harvard.edu


Publications:

Responsible Party: Diego A. Pizzagalli, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01253421     History of Changes
Other Study ID Numbers: 2010-P001568
R01MH068376 ( U.S. NIH Grant/Contract )
First Submitted: December 1, 2010
First Posted: December 3, 2010
Results First Submitted: May 2, 2017
Results First Posted: January 18, 2018
Last Update Posted: April 27, 2018