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

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9
participants needed

84
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University of Cincinnati

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Updated on 19 February 2024

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anxiety

depressive disorder

citalopram

panic disorder

duloxetine

depression

depo-provera

progestin

separation

urine drug screen

clonazepam

major depressive disorder

pregabalin

norplant

escitalopram

nuvaring

evra

implanon

oral contraceptives

Summary

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

Description

The study will consist of 2 phases (Figure 1). Eighty-four adults will be enrolled in Phase 1 and will be adaptively randomized (initially 1:1) to acute, double-blind treatment with escitalopram or duloxetine for 11 weeks. Remission status will be determined at week 10. Remitting patients (CGI-S 2) will resume treatment as usual, which may consist of outpatient referral. Non-remitting patients (CGI-S 3), will continue into Phase 2 and will be randomized to adjunctive clonazepam or pregabalin for 8 weeks. Twenty adults treated with escitalopram (or its racemic equivalent, citalopram) or duloxetine for 6 weeks (at screening) will be enrolled into Phase 2 and will be randomized to receive adjunctive clonazepam or pregabalin for 8 weeks.

Details

Condition	Endogenous depression, Depression, Depression, Anxious Depression
Age	18years - 50years
Treatment	Duloxetine, Escitalopram
Clinical Study Identifier	NCT04245748
Sponsor	University of Cincinnati
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Written, informed consent
	Patients must be fluent in the English
	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
	Surgical sterilization
	Oral contraceptives (e.g. estrogren-progestin combination or progestin)
	Transdermally-delivered contraceptives (e.g., Ortho-Evra), depot injections (e.g., Depo-Provera)
	Vaginal contraceptive ring (e.g., NuvaRing), contraceptive implants (e.g., Implanon, Norplant II/Jadelle)
	An intrauterine device
	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
Exclusion Criteria
	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

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Study Definition

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