Generalized Anxiety Disorder Clinical Trial
Official title:
An Open Label Study of Clinical Utility and Patient Outcomes of the Genecept Assay
Genomind has developed and introduced a battery of genetic tests, the Genecept Assay, which clinicians can administer to patients using a simple saliva sample technique. The present study proposes to enroll 1. Subjects (patients who have consented to using the Genecept Assay) and 2. Clinician study participants (clinicians who have ordered the Assay on behalf of their patients). This study will involve the collection of responses from both Subjects and clinician study participants with the intention of correlating this information to Subject genetic data.
This will be a 3-month prospective study of clinicians who have ordered the Genecept assay
and the psychiatric patients for whom the test was ordered. Clinicians who order the Assay
for a patient who has been indicated as having a diagnosis of depression will receive an
invitation to participate in this study as well as an informational patient study brochure
with the test kit. The patient's treating clinician will be prompted to discuss the study
with the patient. Clinicians and patients can view a website containing additional
information about the study as well as the informed consent document.
Potential subjects and clinician study participants will be consented online using a secure
electronic method. Study staff will be available by phone and by email to answer any
questions related to the study and the informed consent documents and process. Clinicians
and patients can choose to participate independently of each other so that if one party
declines to enroll, the other may still participate. Whether or not they choose to
participate, patients must consent to allow their clinicians to provide responses about
their treatment.
All subjects and participants will receive a username and password with which to access the
secure study portal for completion of study surveys. Subjects and participants will receive
sms and email reminders when surveys are due.
At baseline, clinician study participants will supervise DNA sample collection and will be
prompted to complete a brief survey containing questions about the patient's psychiatric
history and severity of illness, current treatment regimen and the treatment intentions of
the clinician prior to receiving genetic results. After receiving the results of the Assay,
clinician study participants will again be prompted to complete an online study survey
containing questions related to the impact of the Genecept Assay on treatment and diagnosis
decisions. The subject will continue with treatment as determined by the clinician study
participant. At 3 months from baseline, clinician study participants will again be asked to
complete an online survey with additional questions related to subsequent changes to the
patient's treatment regimen and illness severity since receiving/implementing the results of
the Assay.
The subject will also be prompted to complete surveys at baseline, 1 month from the receipt
of the genetic results and 3 months from the receipt of the genetic results. These surveys
include questions about the patient's psychiatric symptoms, quality of life and medication
side effects. The 3 month patient assessment will also include a satisfaction questionnaire.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03420456 -
Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study
|
N/A | |
| Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
| Withdrawn |
NCT02382224 -
Worry Exposure for Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
| Completed |
NCT02306356 -
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
|
N/A | |
| Completed |
NCT01958788 -
Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT01681329 -
Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT01201967 -
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
|
Phase 4 | |
| Completed |
NCT01337713 -
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
|
N/A | |
| Completed |
NCT01342120 -
PHARMO Institute Seroquel Safety Study
|
N/A | |
| Completed |
NCT01971203 -
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
|
N/A | |
| Completed |
NCT01203293 -
Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
|
Phase 1 | |
| Completed |
NCT00961298 -
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
|
Phase 4 | |
| Terminated |
NCT01244711 -
Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
|
Phase 4 | |
| Completed |
NCT00744627 -
Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.
|
Phase 3 | |
| Completed |
NCT00711737 -
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
|
N/A | |
| Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
| Completed |
NCT00537615 -
An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT00515242 -
Therapeutic Massage for Generalized Anxiety Disorder
|
Phase 1/Phase 2 | |
| Completed |
NCT00368745 -
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
|
Phase 3 |