Genomics Used to Improve DEpression Decisions

Completed · Not applicable

Conditions studied: Major Depressive Disorder (MDD)

In brief

Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study.

Key facts

Study ID

NCT02109939

Run by

Assurex Health Inc.

People needed

1398

Starts

2014-04-01

Expected to finish

2017-07-31

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated ICF will be obtained from each patient before participation in the study;
• Have provided written authorization for the use and disclosure of their protected health information;
• Be ≥18 years of age;
• Suffer from a Major Depressive Episode meeting DSM-IV-TR criteria;
• Have had an inadequate response within the current episode to at least 1 psychotropic treatment. Inadequate response is defined as inadequate efficacy after 6 weeks of a psychotropic treatment or discontinuation of a psychotropic treatment due to AEs or intolerability;
• Have a total baseline score on the QIDS-C16 and QIDS-SR16 rating scale ≥11;
• Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.

You may not qualify if…

• Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator;
• Patients with a diagnosis of Bipolar I or II disorder;
• Patients with a current Axis I diagnosis of:
• Delirium
• Dementia
• Amnestic and other cognitive disorder
• Schizophrenia or other psychotic disorder;
• Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes;
• Patient is currently in an inpatient facility;
• Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
• Patients who meet DSM-IV-TR criteria for any significant current substance use disorder;
• Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X ULN for AST and/or ALT); liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications;
• Participation in another clinical trial within 30 days of the screening visit;
• Anticipated inability to attend scheduled study visits;
• Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
• Patients with a history of prior pharmacogenomic testing;
• Any change in psychotropic medication (including change in dosage) between screening and randomization;
• Patients receiving ECT, DBS or TMS treatment (should a Subject receive any of these treatments they must be discontinued from the study);
• Patients who are known to be pregnant or lactating;
• Patients with a history of gastric bypass surgery.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• CiTrials — Bellflower, California, United States
• Catalina Research Institute — Chino, California, United States
• CiTrials — Costa Mesa, California, United States
• Synergy Research Center — Escondido, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• North County Research — Oceanside, California, United States
• CiTrials — Riverside, California, United States
• Stanford School of Medicine — Stanford, California, United States
• Viking Clinical Research — Temecula, California, United States
• Elite Clinical Trials, Inc — Wildomar, California, United States
• MCB Clinical Research Centers, LLC — Colorado Springs, Colorado, United States
• Howard University Hospital Mental Health Clinic — Washington D.C., District of Columbia, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Clinical Neuroscience Solutions Healthcare — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions — Orlando, Florida, United States
• Clinical Research Trials of Florida, Inc — Tampa, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Janus Center For Psychiatric Research — West Palm Beach, Florida, United States
• Atlanta Institute of Medicine and Research — Atlanta, Georgia, United States
• Mood and Anxiety Program at Emory University — Atlanta, Georgia, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Birmingham Psychiatry Pharmaceutical Studies — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.