Pharmacogenetic-Directed Treatment for Major Depression

NCT01261364 | Completed DMC

• 1 other identifier: 10002
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Keywords

GeneSight; Assurex; AssureRx

Outcome Measures

Primary Outcomes (2)

• Depression Score reduction

  Mean change in the 17 item Grid Hamilton Depression (HAMD17) score from baseline at each assessment.

  8 weeks

• Side effect reduction

  Mean change in the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) score from baseline at each assessment.

  8 weeks

Secondary Outcomes (8)

• Depression response or remission

  8 weeks

• Time to response/remission of depressive symptoms.

  8 weeks

• Medication change

  8 weeks

• Health care clinical cost

  8 weeks

• Report availability

  8 weeks

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Behavioral: Treatment as usual

Pharmacogenetic guided treatment

EXPERIMENTAL

Behavioral: GeneSightRx

Interventions

GeneSightRx BEHAVIORAL

Multi-genetic pharmacogenomic panel

Pharmacogenetic guided treatment

Treatment as usual BEHAVIORAL

Treatment as usual

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assurex Health Inc.: lead
• Pine Rest Christian Mental Health Services: collaborator

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kevin Furmaga, PharmD

  Pine Rest Mental Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 16, 2010
• Study Start: September 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 3, 2015

Record last verified: 2015-12