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Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep

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ClinicalTrials.gov Identifier: NCT02189213
Recruitment Status : Terminated (Insufficient funding)
First Posted : July 14, 2014
Results First Posted : October 11, 2021
Last Update Posted : October 11, 2021
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Amir A. Levine, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Generalized Anxiety Disorder
Separation Anxiety Disorder
Social Phobia
Intervention Drug: Sertraline
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sertraline Healthy Control
Hide Arm/Group Description

Sertraline was administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:

Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks, or, the titration was stopped at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration.

Healthy control will not be treated.
Period Title: Overall Study
Started 13 1
Completed 7 1
Not Completed 6 0
Arm/Group Title Sertraline Control Total
Hide Arm/Group Description

Sertraline will be administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:

Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks, or the titration will stop at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration.

There will be no intervention in this arm. Total of all reporting groups
Overall Number of Baseline Participants 13 1 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 1 participants 14 participants
<=18 years
12
  92.3%
0
   0.0%
12
  85.7%
Between 18 and 65 years
1
   7.7%
1
 100.0%
2
  14.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 1 participants 14 participants
Female
8
  61.5%
1
 100.0%
9
  64.3%
Male
5
  38.5%
0
   0.0%
5
  35.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 1 participants 14 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  15.4%
1
 100.0%
3
  21.4%
White
11
  84.6%
0
   0.0%
11
  78.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 1 participants 14 participants
13 1 14
1.Primary Outcome
Title Clinical Global Impression-Improvement (CGI-I) Score
Hide Description

The CGI-I score at the final visit will determine treatment response.

The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale.

The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.

CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment.

Time Frame Final visit, at 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
There were two males and two females in the responder group and two females and one male in the non-responder group.
Arm/Group Title Sertraline Responders Sertraline Non-Responders
Hide Arm/Group Description:

Responders will have either a score of 1 or 2 on the Clinical Global Impressions (CGI) Improvement Scale. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale.

The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.

CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment.

Non-Responders will have a score of 3 or greater than 3 on the Clinical Global Impressions (CGI) Improvement Scale. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale.

The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.

CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment.

Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.00  (1.40) 3.66  (2.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sertraline Responders, Sertraline Non-Responders
Comments At least 50% of subjects will respond to Sertraline treatment (CGI greater than or equal to 2).
Type of Statistical Test Other
Comments The parameters were the CGI-Improvement scale which comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The hypothesis is that ~50% of subjects receiving treatment will not respond.
Statistical Test of Hypothesis P-Value =0.0002
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse event data was collected for 12 weeks during the duration the patients were receiving medications. Only participants who were treated and healthy controls were monitored/assessed for adverse events.
Adverse Event Reporting Description We collected adverse events using the Pediatric Adverse Event Rating Scale (PAERS-Clinician)
 
Arm/Group Title Sertraline Healthy Control
Hide Arm/Group Description

Sertraline was administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:

Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks, or, the titration was stopped at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration.

Healthy control will not be treated.
All-Cause Mortality
Sertraline Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Sertraline Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sertraline Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Amir Levine
Organization: RFMH
Phone: 646 481 2566
EMail: amir.levine@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: Amir A. Levine, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02189213    
Other Study ID Numbers: 6884
First Submitted: July 7, 2014
First Posted: July 14, 2014
Results First Submitted: June 22, 2021
Results First Posted: October 11, 2021
Last Update Posted: October 11, 2021