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Trial record 22 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

A Controlled Trial of Serotonin Reuptake Inhibitors Added to Stimulant Medication in Youth With Severe Mood Dysregulation

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ClinicalTrials.gov Identifier: NCT00794040
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Mood Disorder
Mental Disorder Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorder
Attention Deficit Hyperactivity Disorder
Interventions Drug: Add-on citalopram following optimized methylphenidate
Drug: Add-on placebo following optimized methylphenidate
Enrollment 103
Recruitment Details Recruitment was conducted at the National Institute of Mental Health Division of Intramural Research Programs (NIMH DIRP) from November 2008 until January 2018. The inpatient part of the study took place at the Child Psychiatric Unit of the NIH Clinical Center.
Pre-assignment Details Enrolled participants (N=103) went through a medication wash-out period. n=22 participants withdrew assent before or during this period, and 12 participants met exclusion criteria. Then 69 participants began methylphenidate optimization; of those, 4 withdrew assent, 12 did not meet inclusion criteria. n=53 were randomized, and 49 analyzed.
Arm/Group Title Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Hide Arm/Group Description After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
Period Title: Overall Study
Started 25 28
Completed 22 23
Not Completed 3 5
Reason Not Completed
Withdrawal by Subject             3             4
Physician Decision             0             1
Arm/Group Title Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate Total
Hide Arm/Group Description After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm) Total of all reporting groups
Overall Number of Baseline Participants 23 26 49
Hide Baseline Analysis Population Description
Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 26 participants 49 participants
11.4  (2.5) 11.7  (2.1) 11.6  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 49 participants
Female
10
  43.5%
6
  23.1%
16
  32.7%
Male
13
  56.5%
20
  76.9%
33
  67.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 49 participants
Hispanic or Latino
3
  13.0%
3
  11.5%
6
  12.2%
Not Hispanic or Latino
20
  87.0%
22
  84.6%
42
  85.7%
Unknown or Not Reported
0
   0.0%
1
   3.8%
1
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 49 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.3%
0
   0.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  11.5%
3
   6.1%
White
19
  82.6%
20
  76.9%
39
  79.6%
More than one race
3
  13.0%
2
   7.7%
5
  10.2%
Unknown or Not Reported
0
   0.0%
1
   3.8%
1
   2.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants 26 participants 49 participants
23
 100.0%
26
 100.0%
49
 100.0%
Clinical Global Impression - Severity (CGI-S) collected at Admission   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 26 participants 49 participants
4.4  (0.6) 4.6  (0.5) 4.5  (0.5)
[1]
Measure Description: A measure of severity of irritability scale (from 1=Normal, not at all ill to 7=Among the most extremely ill patients). Two graduate-level, highly-experienced clinicians completed weekly the CGI, with child and parent/nursing staff as a source of information. Ratings were reached by consensus in a case conference with a senior child and adolescent psychiatrist (KT); all clinicians and participants were blind to the treatment condition.
Children’s Global Assessment of Severity (CGAS) collected at Admission   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 26 participants 49 participants
44  (6.1) 41.7  (2.2) 42.8  (4.5)
[1]
Measure Description: A measure of overall functional impairment with scores ranging from 1=Most impaired to 100=Not impaired at all.
Children’s Depression Rating Scale (CDRS) collected at Admission   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 26 participants 49 participants
29.7  (5.9) 32.0  (7.6) 30.1  (6.9)
[1]
Measure Description: A measure of depressive symptoms severity ranging 17-113, where scores >40 are considered over the clinical threshold, and scores <28 are considered within the healthy range.
Pediatric Anxiety Rating Scale (PARS) collected at Admission   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 26 participants 49 participants
15.7  (4.5) 14.8  (4.7) 15.1  (4.8)
[1]
Measure Description: A measure of anxiety symptoms severity with scores ranging 0-25. Higher values represent a worse outcome.
Psychiatric disorders information collected at Admission using the K-SADS-PL   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 26 participants 49 participants
Any disorder
23
 100.0%
26
 100.0%
49
 100.0%
Attention Deficit Hyperactivity Disorder
20
  87.0%
24
  92.3%
44
  89.8%
Oppositional Defiant Disorder
17
  73.9%
22
  84.6%
39
  79.6%
Conduct Disorder
0
   0.0%
1
   3.8%
1
   2.0%
Any Anxiety disorder
13
  56.5%
15
  57.7%
28
  57.1%
[1]
Measure Description: Presence of co-occurring psychiatric disorders at the time of enrollment to study measured with a semi-structured interview, the Kiddie Schedule for Affective Disorders Present and Lifetime Version (K-SADS-PL).
Clinical Global Impression - Severity (CGI-S) collected before Randomization   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 26 participants 49 participants
4.0  (0.5) 4.3  (0.6) 4.2  (0.6)
[1]
Measure Description: A measure of severity of irritability scale (from 1=Normal, not at all ill to 7=Among the most extremely ill patients). Two graduate-level, highly-experienced clinicians completed weekly the CGI, with child and parent/nursing staff as a source of information. Ratings were reached by consensus in a case conference with a senior child and adolescent psychiatrist (KT); all clinicians and participants were blind to the treatment condition.
Children’s Global Assessment of Severity (CGAS) collected before Randomization   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 26 participants 49 participants
44.4  (3.3) 42.9  (3.6) 43.6  (3.5)
[1]
Measure Description: A measure of overall functional impairment with scores ranging from 1=Most impaired to 100=Not impaired at all
Children’s Depression Rating Scale (CDRS) collected before Randomization   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 26 participants 49 participants
29.4  (5.7) 34.6  (8.6) 32.1  (7.7)
[1]
Measure Description: A measure of depressive symptoms severity ranging 17-113, where scores >40 are considered over the clinical threshold, and scores <28 are considered within the healthy range
Pediatric Anxiety Rating Scale (PARS) collected before Randomization   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 26 participants 49 participants
13.3  (5.9) 15.8  (5.2) 14.8  (5.4)
[1]
Measure Description: A measure of anxiety symptoms severity with scores ranging 0-25. Higher values represent a worse outcome.
1.Primary Outcome
Title Percentage of Participants That "Much Improved" (Score of 2) in, or "Completely Recovered" (Score of 1) From Their Irritability Severity, as Measured With the Clinical Global Impression-Improvement (CGI-I).
Hide Description

A measure of change of irritability severity taking the baseline before randomization as a reference. Scores range 1 to 8, in which 1=Completely recovered,... 5=Unchanged,... 8=Much worse.

Percentage of participants who responded are based on an estimation and might not match exactly with discrete numbers of participants based on the denominator.

Time Frame Collected weekly during the 8-week trial. The 8th-week outcome is reported.
Hide Outcome Measure Data
Hide Analysis Population Description
Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants
Arm/Group Title Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Hide Arm/Group Description:
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
Overall Number of Participants Analyzed 23 26
Measure Type: Number
Unit of Measure: estimated percentage of participants
35 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Add-on Citalopram Following Optimized Methylphenidate, Add-on Placebo Following Optimized Methylphenidate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments priori threshold p<0.05
Method Multilevel growth curve model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.7
Confidence Interval (2-Sided) 95%
2.00 to 68.16
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Irritability Severity at 8th Week of Trial.
Hide Description Clinical Global Impression-Severity (CGI-S): A measure of severity of irritability scale (from 1=Normal, not at all ill to 7=Among the most extremely ill patients).
Time Frame Collected weekly during the 8th week trial. The 8th-week outcome is reported.
Hide Outcome Measure Data
Hide Analysis Population Description
Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.
Arm/Group Title Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Hide Arm/Group Description:
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
Overall Number of Participants Analyzed 23 26
Mean (Standard Error)
Unit of Measure: units on a scale
3.1  (0.3) 3.9  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Add-on Citalopram Following Optimized Methylphenidate, Add-on Placebo Following Optimized Methylphenidate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments priori threshold <0.05
Method Multilevel growth curve model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-1.32 to 0.09
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Functional Impairment at 8th Week of Trial
Hide Description Difference in functional impairment at 8th week of trial as measured with Children's Global Impression Scale (CGAS) with scores ranging from 1=Most impaired to 100=Not impaired at all.
Time Frame Collected weekly during the 8th week trial. The 8th-week outcome is reported.
Hide Outcome Measure Data
Hide Analysis Population Description
Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.
Arm/Group Title Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Hide Arm/Group Description:
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
Overall Number of Participants Analyzed 23 26
Mean (Standard Error)
Unit of Measure: units on a scale
52.6  (2.3) 47.2  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Add-on Citalopram Following Optimized Methylphenidate, Add-on Placebo Following Optimized Methylphenidate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments priori threshold p<0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.72
Confidence Interval (2-Sided) 95%
-1.30 to 10.74
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Depressive Symptoms at 8th Week of Trial
Hide Description Difference in depressive symptoms at 8th week of trial as measured with Children’s Depression Rating Scale (CDRS) with scores ranging 17-113, where scores >40 are considered over the clinical threshold, and scores <28 are considered within the healthy range.
Time Frame Collected weekly during the 8th week trial. The 8th-week outcome is reported.
Hide Outcome Measure Data
Hide Analysis Population Description
Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.
Arm/Group Title Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Hide Arm/Group Description:
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
Overall Number of Participants Analyzed 23 26
Mean (Standard Error)
Unit of Measure: units on a scale
28.6  (1.8) 30.1  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Add-on Citalopram Following Optimized Methylphenidate, Add-on Placebo Following Optimized Methylphenidate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments priori threshold p<0.05
Method Multilevel growth curve model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-4.76 to 4.80
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Anxiety Symptoms at 8th Week of Trial
Hide Description Difference in anxiety symptoms at 8th week of trial as measured with the Pediatric Anxiety Rating Scale (PARS) with scores ranging 0-25. Higher values represent a worse outcome.
Time Frame Collected weekly during the 8th week trial. The 8th-week outcome is reported.
Hide Outcome Measure Data
Hide Analysis Population Description
Whereas 53 participants were randomized, 49 participants were analyzed using intent-to-treat analysis. The first 4 participants recruited were excluded because a different version of the primary outcome measure (i.e., CGI) was collected in these participants and therefore was not comparable to the remaining participants.
Arm/Group Title Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Hide Arm/Group Description:
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo
After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
Overall Number of Participants Analyzed 23 26
Mean (Standard Error)
Unit of Measure: units on a scale
12.0  (1.2) 13.4  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Add-on Citalopram Following Optimized Methylphenidate, Add-on Placebo Following Optimized Methylphenidate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.598
Comments priori threshold p<0.05
Method Multilevel growth curve model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
-4.23 to 2.19
Estimation Comments [Not Specified]
Time Frame Adverse event information was collected weekly during the study, including the 8th weeks of the trial.
Adverse Event Reporting Description Adverse events were ascertained by checklists. These were completed by nurses (during inpatient admission) or parents (after discharge), all of whom were blind to treatment assignment, and instructed to rate what they observed without reference to changes from baseline irritability, time of day or severity of the presentation. Information on suicidality and manic symptoms were also routinely collected.
 
Arm/Group Title Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Hide Arm/Group Description After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram (this arm) or placebo After optimized treatment with methylphenidate, those who meet threshold for chronic irritability are randomized to add-on citalopram or placebo (this arm)
All-Cause Mortality
Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/26 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Add-on Citalopram Following Optimized Methylphenidate Add-on Placebo Following Optimized Methylphenidate
Affected / at Risk (%) Affected / at Risk (%)
Total   23/23 (100.00%)   24/26 (92.31%) 
Cardiac disorders     
Change in heart rate fast/slow   1/23 (4.35%)  2/26 (7.69%) 
Ear and labyrinth disorders     
Ringing or buzzing in ears   0/23 (0.00%)  2/26 (7.69%) 
Eye disorders     
Eyes sensitive to light   1/23 (4.35%)  2/26 (7.69%) 
Gastrointestinal disorders     
Dry mouth   3/23 (13.04%)  4/26 (15.38%) 
Drooling   2/23 (8.70%)  0/26 (0.00%) 
Increased thirst   3/23 (13.04%)  3/26 (11.54%) 
Trouble swallowing   2/23 (8.70%)  3/26 (11.54%) 
Nausea   10/23 (43.48%)  8/26 (30.77%) 
Vomiting   5/23 (21.74%)  3/26 (11.54%) 
Stomach pains   13/23 (56.52%)  16/26 (61.54%) 
Bloated abdomen   3/23 (13.04%)  0/26 (0.00%) 
Changes in stool   8/23 (34.78%)  6/26 (23.08%) 
General disorders     
Tiredness/fatigue   12/23 (52.17%)  9/26 (34.62%) 
Insomnia   17/23 (73.91%)  24/26 (92.31%) 
Early morning awakening   3/23 (13.04%)  3/26 (11.54%) 
Appetite changes   23/23 (100.00%)  21/26 (80.77%) 
Weight changes   13/23 (56.52%)  13/26 (50.00%) 
Fever   1/23 (4.35%)  3/26 (11.54%) 
Headache   11/23 (47.83%)  12/26 (46.15%) 
Runny nose   6/23 (26.09%)  7/26 (26.92%) 
Easy bruising   2/23 (8.70%)  2/26 (7.69%) 
Musculoskeletal and connective tissue disorders     
Restless/Inability to sit still   16/23 (69.57%)  19/26 (73.08%) 
Stiffness/Involuntary movements   2/23 (8.70%)  5/26 (19.23%) 
Extreme stiffness/Lack of movement   2/23 (8.70%)  0/26 (0.00%) 
Muscle twitches   1/23 (4.35%)  2/26 (7.69%) 
Motor tics   8/23 (34.78%)  11/26 (42.31%) 
Nervous system disorders     
Drowsiness morning/afternoon   7/23 (30.43%)  3/26 (11.54%) 
Dizziness   5/23 (21.74%)  1/26 (3.85%) 
Psychiatric disorders     
Anger   19/23 (82.61%)  22/26 (84.62%) 
Agression   17/23 (73.91%)  12/26 (46.15%) 
Nervousness   15/23 (65.22%)  13/26 (50.00%) 
Clingy/separation anxiety   13/23 (56.52%)  8/26 (30.77%) 
Loss of interest/apathy   7/23 (30.43%)  6/26 (23.08%) 
Poor concentration   9/23 (39.13%)  8/26 (30.77%) 
Disorganized thinking   2/23 (8.70%)  1/26 (3.85%) 
Speech changes   7/23 (30.43%)  6/26 (23.08%) 
Intrusiveness   17/23 (73.91%)  15/26 (57.69%) 
Renal and urinary disorders     
Enuresis   1/23 (4.35%)  2/26 (7.69%) 
Respiratory, thoracic and mediastinal disorders     
Difficulty breathing   3/23 (13.04%)  2/26 (7.69%) 
Severe or chronic cough   2/23 (8.70%)  1/26 (3.85%) 
Whezzing   2/23 (8.70%)  1/26 (3.85%) 
Skin and subcutaneous tissue disorders     
Rash/itch   8/23 (34.78%)  5/26 (19.23%) 
Increased sweating   2/23 (8.70%)  1/26 (3.85%) 
Dry skin   2/23 (8.70%)  1/26 (3.85%) 
Hair changes   0/23 (0.00%)  2/26 (7.69%) 
Acne   4/23 (17.39%)  1/26 (3.85%) 
Picking at skin or nails   5/23 (21.74%)  2/26 (7.69%) 
Indicates events were collected by systematic assessment
The sample size was smaller than initially planned. Our primary measure of irritability Aberrant Behavior Checklist - Irritability subscale, did not prove suitable for the current study due to its design (i.e., different environments and informants)
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: Dr Argyris Stringaris
Organization: Mood, Brain and Development Unit, Emotion and Development Branch, National Institute of Mental Health, National Institutes of Health
Phone: (301) 443-8019
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00794040     History of Changes
Other Study ID Numbers: 090034
09-M-0034
First Submitted: November 18, 2008
First Posted: November 19, 2008
Results First Submitted: March 22, 2019
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019