RECRUITING

Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Acute, double-blind, adaptively randomized treatment with duloxetine or escitalopram, followed by double-blind, randomized adjunctive treatment with clonazepam or pregabalin for persistent symptoms.

Official Title

Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)

Quick Facts

Study Start:2020-03-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04245748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Written, informed consent. * Patients must be fluent in the English. * 18 to 50 years of age, inclusive, at Visit 1. * Patients must meet DSM-5 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI.99 Patients may also meet criteria for persistent depressive disorder or major depressive disorder however, these may not be the primary focus of treatment. * HAM-A score ≥20 at Visits 1 and 2. * Clinical Global Impressions- Severity (CGI-S) score ≥4 at Visits 1 and 2. * No clinically significant abnormalities on physical examination and EKG. * Negative pregnancy test at Visit 1 in females. * Negative urine drug screen at Visit 1. * Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted: 1. Surgical sterilization 2. Oral contraceptives (e.g. estrogren-progestin combination or progestin) 3. Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera) 4. Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle) 5. An intrauterine device 6. Diaphragm plus condom. * For patients directly enrolling into Phase 2: treatment with escitalopram (or its racemic equivalent citalopram) or duloxetine for ≥6 weeks, at time of screening.	* DSM-5 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment. * A history of intellectual disability. * Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator. * Allergy, intolerance, non-response or hypersensitivity to escitalopram, duloxetine, pregabalin or clonazepam. * Subjects taking other medications that require a taper or washout of more than 5 days. * Patients who have initiated/terminated psychotherapy/behavior therapy within 1 month before Visit 2 (Baseline) will be excluded; if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline. * A clinically-significant medical illness. * QTc \>450 in males or \>460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG100 * Alcohol or substance use disorder within 6 months of baseline (nicotine use is permitted). * Positive urine pregnancy test/pregnancy or breast feeding. * A positive urine drug screen. * Patients who are unable to swallow capsules.

Inclusion Criteria

Exclusion Criteria

* Written, informed consent.
* Patients must be fluent in the English.
* 18 to 50 years of age, inclusive, at Visit 1.
* Patients must meet DSM-5 criteria for generalized, social and/or separation anxiety disorder and/or panic disorder, confirmed by the MINI.99 Patients may also meet criteria for persistent depressive disorder or major depressive disorder however, these may not be the primary focus of treatment.
* HAM-A score ≥20 at Visits 1 and 2.
* Clinical Global Impressions- Severity (CGI-S) score ≥4 at Visits 1 and 2.
* No clinically significant abnormalities on physical examination and EKG.
* Negative pregnancy test at Visit 1 in females.
* Negative urine drug screen at Visit 1.
* Sexually active patients must practice a reliable method of contraception (Section 15.0) that will continue for the duration of the study and for a minimum of 30 days following the end of study participation. Reliable methods of contraception are defined below; other forms of contraceptives (pharmacological and/or non-pharmacological) are not accepted:
1. Surgical sterilization
2. Oral contraceptives (e.g. estrogren-progestin combination or progestin)
3. Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
4. Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
5. An intrauterine device
6. Diaphragm plus condom.
* For patients directly enrolling into Phase 2: treatment with escitalopram (or its racemic equivalent citalopram) or duloxetine for ≥6 weeks, at time of screening.

* DSM-5 diagnosis other than generalized anxiety, social anxiety, separation anxiety or panic disorder(s) that is the primary focus of treatment.
* A history of intellectual disability.
* Suicide risk as determined by either: (1) any suicide attempt within the past 6 months and/or (2) significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the Investigator.
* Allergy, intolerance, non-response or hypersensitivity to escitalopram, duloxetine, pregabalin or clonazepam.
* Subjects taking other medications that require a taper or washout of more than 5 days.
* Patients who have initiated/terminated psychotherapy/behavior therapy within 1 month before Visit 2 (Baseline) will be excluded; if the patient is engaged in psychotherapy, it must have been stable for 1 month prior to baseline.
* A clinically-significant medical illness.
* QTc \>450 in males or \>460 in females (prolonged QTc based on American Heart Association recommendations for Standardization and Interpretation of the EKG100
* Alcohol or substance use disorder within 6 months of baseline (nicotine use is permitted).
* Positive urine pregnancy test/pregnancy or breast feeding.
* A positive urine drug screen.
* Patients who are unable to swallow capsules.

Contacts and Locations

Study Contact

Heidi K Schroeder, BS

CONTACT

(513) 558-4422

heysehk@uc.edu

Zoe N Neptune, BS

CONTACT

(513) 558-2866

neptunza@uc.edu

Principal Investigator

Jeffrey R Strawn, MD, FAACAP

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Study Locations (Sites)

University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Cincinnati, Ohio, 45219

United States

Collaborators and Investigators

Sponsor: University of Cincinnati

Jeffrey R Strawn, MD, FAACAP, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-03-01

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Anxious Depression

Additional Relevant MeSH Terms

Anxious Depression
Depression