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Pharmacogenetic-Directed Treatment for Major Depression

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ClinicalTrials.gov Identifier: NCT01261364
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Determine if antidepressant treatment guided by pharmacogenetic algorithm and interpretive report improves outcomes when compared with standard treatment without the availability of genetic information.

Condition or disease Intervention/treatment
Depression Behavioral: GeneSightRx Behavioral: Treatment as usual

Detailed Description:
This study is designed to evaluate the clinical impact of pharmacogenetic (PGx)-directed treatment, as guided by interpretive, algorithmic report in the Pine Rest outpatient behavioral health clinics. The PGx algorithm utilized in this study is the foundation of a novel method of interpreting genetic testing results and reports them in a rapidly delivered format that provides enhanced guidance to psychiatrists in their selection of antidepressant medications

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting:A Randomized Double Blind Pilot Study
Study Start Date : September 2009
Primary Completion Date : January 2011
Study Completion Date : September 2011
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Treatment as Usual Behavioral: Treatment as usual
Treatment as usual
Experimental: Pharmacogenetic guided treatment Behavioral: GeneSightRx
Multi-genetic pharmacogenomic panel

Outcome Measures

Primary Outcome Measures :
  1. Depression Score reduction [ Time Frame: 8 weeks ]
    Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.

  2. Side effect reduction [ Time Frame: 8 weeks ]
    Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.

Secondary Outcome Measures :
  1. Depression response or remission [ Time Frame: 8 weeks ]
    Percentage of subjects who respond (≥50% decrease in HAMD17 and QIDS-CR* rating) or remit (HAMD17< 7 and QIDS-CR rating < 5) with PGx-guided treatment.

  2. Time to response/remission of depressive symptoms. [ Time Frame: 8 weeks ]
    Time to response/remission of depressive symptoms.

  3. Medication change [ Time Frame: 8 weeks ]
    Number of subjects who changed their baseline antidepressant medication regimens.

  4. Health care clinical cost [ Time Frame: 8 weeks ]
    Health care clinical cost (defined by mental health resource utilization).

  5. Report availability [ Time Frame: 8 weeks ]
    Percent of time that the PGx interpretive report is completed and available to the psychiatrist/nurse practitioner prior to seeing the patient.

  6. Medication Choice [ Time Frame: 8 weeks ]
    Proportion of time that the psychiatrist/nurse practitioner prescribed a medication that was recommended by the algorithm.

  7. Physician satisfaction [ Time Frame: 8 weeks ]
    Physician satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).

  8. Patient Satisfaction [ Time Frame: 8 weeks ]
    Patient satisfaction with delivery of clinical care (defined by a researcher-developed Likert-based satisfaction survey).

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of Major Depressive Disorder (296.2, 296.3) or Depressive Disorder NOS (311.0) by a board certified psychiatrist.
  • The patient is referred to the study by their treating psychiatrist or nurse practitioner who is approved by the study investigators to make subject referrals to the study.
  • The patient is an outpatient and not in imminent need of inpatient hospitalization for medical or psychiatric reasons.
  • Patient's baseline 17-Item Hamilton Depression (HAMD17) Rating score is >14.
  • Provide a copy of a physical exam report performed within 6 months prior to study enrollment or undergo a physical exam by either their personal physician, a physician who is a subinvestigator on the study, or a study-contracted physician assistant in internal medicine.
  • Undergo a medical history that includes a review of major organ systems by either their treating clinician, a subinvestigator physician, or a study-contracted physician assistant in internal medicine.
  • The patient has signed the study informed consent form.

Exclusion Criteria:

  • Serious medical illness (as ascertained via inclusion criteria 6 and 7, above).
  • Diagnosis of a Bipolar Disorder.
  • Diagnosis of Schizophrenia or Schizoaffective disorder.
  • Evidence from history, baseline urine drug screen, and/or psychiatric interview of active abuse of alcohol and/or other drugs of abuse within 6 months prior to study enrollment. Patients who occasionally use marijuana may still be eligible if it is determined through psychiatric interview that the level of use does not qualify as abuse, dependence, or addiction. Patients testing positive for opioids or benzodiazepines are eligible if there is no evidence of abuse and it is determined that they are taking opioid analgesics or a benzodiazepine that is prescribed by a licensed prescriber for a medical or psychiatric indication.
  • History of prior pharmacogenomic testing.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261364

Sponsors and Collaborators
Assurex Health Inc.
Pine Rest Christian Mental Health Services
Principal Investigator: Kevin Furmaga, PharmD Pine Rest Mental Health Service
More Information

Responsible Party: Assurex Health Inc.
ClinicalTrials.gov Identifier: NCT01261364     History of Changes
Other Study ID Numbers: 10002
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Assurex Health Inc.:

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders