Trial Search Results

International Study to Predict Optimised Treatment - in Depression

The aim of this study is to identify genetic, physical (brain) and psychological (cognitive) markers (or combinations of them) that predict specific response to a range of antidepressants treatment (Escitalopram, Venlafaxine, Sertraline) in patients diagnosed with major depressive disorder. This study is focused on outcomes which may impact on how "personalised medicine" is implemented in depression.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

BRC Operations Pty. Ltd.

Intervention(s):

  • Drug: Escitalopram
  • Drug: Sertraline
  • Drug: Venlafaxine-XR

Phase:

Phase 4

Eligibility


Inclusion Criteria:

   - Meet DSM-IV criteria for primary diagnosis of MDD.

   - HAM-D17 score of ≥ 16.

   - 18-65 years age-range

   - Subjects with English or Dutch literacy and fluency.

   - Written, informed consent.

Exclusion Criteria:

   - Presence of suicidal ideations and/or tendencies (as determined by a score >12 on
   Section C, Suicidality, of the MINI Plus), Bipolar I-III, psychosis, primary eating
   disorders, Post Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD),
   Post-Natal Depression as well as any Axis II personality disorders as diagnosed using
   the MINI Plus or by a health care professional.

   - Pregnancy and women of child bearing potential who are not taking a medically accepted
   form of contraception and are at risk of becoming pregnant during the study.

   - Breastfeeding.

   - Known contra-indication or intolerance to the use of Escitalopram, Sertraline or
   Venlafaxine XR as defined in the product package insert for each drug (including
   previous treatment failure at the highest recommended dose).

   - Use of any psychological or counselling therapy or antidepressant/CNS drug which
   cannot be washed out prior to participation and eliminated until after Week 8 or
   discontinuation.

   - Use of any medication which is known to be contraindicated with Escitalopram,
   Sertraline, or Venlafaxine XR (refer to the product package insert for each drug).

   - Known medical condition, disease or neurological disorder which might, in the opinion
   of investigator/s, interfere with the assessments to be made in the study or put
   subjects at increased risk when exposed to optimal doses of the drug treatment.

   - History of head injury with loss of consciousness for at least 10 minutes.

   - Recent/current substance dependence (as defined in Section K of the Mini Plus as per a
   6 months period and/or alcoholism) in the past six months.

   - Participation in an investigational study within four months of the baseline visit in
   which subjects have received an experimental drug/device that could affect the primary
   end points of this study.

   - Subjects who, in the opinion of the investigator, have a severe impediment to vision,
   hearing and/or hand movement, which is likely to interfere with their ability to
   complete the test batteries.

   - Subjects who, in the opinion of the investigator, are unable and/or unlikely to
   comprehend and follow the study procedures and instructions.

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maureen Chang
7254620
Recruiting