International Study to Predict Optimised Treatment - in Depression

Major Depressive Disorder Clinical Trial

— iSPOT-D  

Official title:

International Study to Predict Optimised Treatment - in Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00693849
• Other study ID #: iSPOT-D
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 2008
• Est. completion date: December 2019

Study information

• Verified date: July 2018
• Source: BRC Operations Pty. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is an open-label, randomised (effectiveness) study (ie. comparison of active treatments) to identify genetic markers, brain function, brain structure, and psychological and cognitive indicators (or a combination of markers) in MDD subjects versus healthy controls. Approximately 2,016 subjects with major depressive disorder (MDD) across multiple international sites (USA, Canada, UK, South Africa, New Zealand, The Netherlands and Australia) will be randomised to one of three approved and effective treatment arms:

Treatment A Escitalopram. Treatment B Sertraline. Treatment C Venlafaxine XR.

A group of matched healthy controls (n = 672) will also be enrolled.

Subjects will be asked to attend the testing facility on two separate occasions; for Pre-treatment (Pre-Tx) and at 8 weeks post initiation of treatment. The assessments/procedures at Pre-Tx and Week 8 include: Baseline a clinical work-up, blood collection for genetic analyses, cognitive testing and electrical brain functioning (EEG/ERP). Structural and functional data MRI data will be collected in ten percent (10%) of participants.

On Day 4 and Weeks 2, 4, 6, 12, 16, 24 and 52 Subjects will be contacted by phone and asked to complete 2 questionnaires via the internet.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2688
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Escitalopram
10 mg/day as a single dose, increased to max 20 mg/day
• Sertraline
50 mg/day as a single dose, increased to max of 200 mg/day
• Venlafaxine-XR
75 mg/day given once daily; increased to 150-225 mg/day

Locations

Country	Name	City	State
Australia	Flinders University	Adelaide	South Australia
Australia	Swinburne University	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Brain Dynamics Centre	Westmead	New South Wales
Netherlands	Brainclinics Diagnostics B.V.	Nijmegen	Gelderland
New Zealand	University of Auckland	Auckland
South Africa	Brain Health Lab	Johannesburg	Guatang
United States	Skyland Behavioral Health Associates , P.A.	Asheville	North Carolina
United States	Shanti Clinical Trials	Colton	California
United States	Ohio State University	Columbus	Ohio
United States	Brain Resource Center	Englewood Cliffs	New Jersey
United States	University of Miami	Miami	Florida
United States	A.D.D. Treatment Center	Mission Viejo	California
United States	Brain Resource Center	New York	New York
United States	NeuroDevelopment Center	Providence	Rhode Island
United States	University of Missouri - St. Louis	Saint Louis	Missouri
United States	Stanford University	Stanford	California
United States	Veteran Affairs/Stanford University	Stanford	California
United States	Center for Healing the Human Spirit	Tarzana	California
United States	Weill Cornell Medical College	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
BRC Operations Pty. Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Netherlands,  New Zealand,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD		Week 8
Secondary	To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.		52-weeks

External Links

•   Australian New Zealand Clinical Trials Registry