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Completed

NCT Number: NCT01261364

Pharmacogenetic-Directed Treatment for Major Depression

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GeneSightRx

Behavioral

Multi-genetic pharmacogenomic panel

Treatment as Usual

Behavioral

Treatment as usual

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Assurex Health Inc.

Industry

Collaborators

  • Pine Rest Christian Mental Health Services

Registry information

Official study title

The Evaluation of the Clinical Impact of the Antidepressant Pharmacogenomic Algorithm in an Outpatient Clinical Setting:A Randomized Double Blind Pilot Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2010
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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