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

NCT02189213 | Terminated Results DMC

• 1 other identifier: 6884
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

1 out of 8 children, adolescents, and young adults suffer from an anxiety disorder. Studies over the past decade show that selective serotonin-reuptake inhibitors (SSRIs), a class of medication that treats anxiety in adults, also works well in young adults, children, and adolescents with anxiety disorders, but only for about 50%. 50% will have undergone treatment for several months before it will be established that the medication is not working to treat the anxiety. The purpose of this study is to find a test that will predict treatment outcome from the beginning based on behavioral and biological measures.

Conditions

Generalized Anxiety Disorder; Separation Anxiety Disorder; Social Phobia

Keywords

anxiety; SSRI; biomarker; sleep; children; adolescents; young adults

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression-Improvement (CGI-I) Score

  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.

  Final visit, at 12 weeks of treatment

Study Arms (2)

Sertraline

ACTIVE COMPARATOR

Sertraline will be administered PO to treat anxiety disorders in children and adolescents. he 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. 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.

Drug: Sertraline

Control

NO INTERVENTION

There will be no intervention in this arm.

Interventions

Sertraline DRUG

Sertraline will be administered to treat anxiety disorders in children and adolescents.

Also known as: Zoloft

Sertraline

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants aged 8-25 years inclusive at the time of the consent/assent, either outpatient or inpatient if hospitalization is required for one of the following reasons:
• It is presently unsafe for subject to stay at home because he/she may run away
• Subject needs closer monitoring while being started on medications
• Subject needs a level of care that is greater than once a week outpatient treatment and is willing to participate in the study.
• Participant's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent by the participant.
• Participant meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) or Fifth Edition (DSM-V) criteria for a clinically impairing anxiety disorder based on detailed psychiatric evaluation at screening including completion of the Anxiety Disorders Interview Schedule for DSM-IV or DSM-V Child Version (ADIS-C) and a Children's Global Assessment Scale (CGAS) score less than 65.
• Participants who are female of child-bearing potential (defined as ≥9 years of age or if \<9 years of age are post-menarchal) must have a negative urine pregnancy test at the Baseline Visit. Females of child-bearing potential must abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception. Condoms should be used with the following acceptable contraceptives:
• Intrauterine devices,
• Hormonal contraceptives (oral, depot, patch, injectable, or vaginal ring).
• Other acceptable contraceptive methods are double barrier methods (e.g., condoms and diaphragms with spermicidal gel or foam).

You may not qualify if:

• Participant has a current co-morbid psychiatric diagnosis of bipolar disorder, psychosis, a pervasive developmental disorder other than Asperger's Syndrome, an eating disorder, substance abuse disorder, or a sleep disorder of narcolepsy and/or sleep apnea.
• Participant has any condition or illness which, in the opinion of the study doctor, represents as an inappropriate risk to the participant and/or could confound the interpretation of the study.
• Participant has received any evidence-based psychosocial intervention in the past 6 weeks i.e. Individual Cognitive Behavioral Therapy, Group Cognitive Behavioral Therapy, or Social Effectiveness Training.
• Participant is unwilling or unable to provide blood, urine, and/or saliva samples at designated visits.
• Participant is female and is pregnant or is currently lactating.
• Participant is currently considered at risk for suicide in the opinion of the study doctor, has made a suicide attempt within the past 6 months, or is currently reporting active suicidal ideation. Participants with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the study doctor. Control participants with any suicidal ideation will not be eligible for the study.
• Participant has had a substance use disorder within the past 6 months.
• Participant has a clinically important abnormality on drug and alcohol screen.
• Participant has started or changed the dosage of medication (including herbal supplements) that has anxiolytic, anxiogenic, or central nervous system (CNS) effects within the past 3 months.
• Participant has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to any components found in the study drug.
• Participant has had several failed attempts with SSRI treatment.
• Participant has an acute illness and/or is taking short term medication at the time of initiation of the study.
• Participant failed screening or was previously enrolled in this study
• Participant is unable to read.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Columbia University: collaborator

Study Sites (1)

NYSPI

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety, Separation; Phobia, Social; Anxiety Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Mental Disorders; Neurodevelopmental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Amir Levine
• Organization: RFMH

amir.levine@nyspi.columbia.edu

646 481 2566

Study Officials

• Amir Levine

  New York State Psychiatric Institue

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist 2/Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 14, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 11, 2021
• Results First Posted: October 11, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)