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

STATUS

Recruiting
days left to enroll

53
participants needed

84
sponsor

University of Cincinnati

Send

Updated on 19 February 2024

See if I qualify

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	18-50 years
Treatment	Duloxetine, Escitalopram
Clinical Study Identifier	NCT04245748
Sponsor	University of Cincinnati
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

major depressive disorder

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

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