International Study to Predict Optimized Treatment - in Depression

International Study to Predict Optimized Treatment response to the three most commonly used antidepressants (Escitalopram, Sertraline and Venlafaxine extended release XR,) in subjects diagnosed with major depressive disorder (MDD) as compared to matched healthy controls.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000476336

Acronym

iSPOT-D

Enrollment

2688

Registered

2008-09-24

Start date

2008-07-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Once randomised and on drug, subjects will be dosed with study medication as per local/country standard of care. Therefore, the length of treatment will differ and is based on the subjects response. escitalopram one 10 mg tablet orally once daily (QD) sertraline one 50 mg orally QD venlafaxine extended release (XR) one 75 mg orally QD

Study design

Allocation

Randomised controlled trial

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)criteria for primary Major Depressive Disorder with a Hamilton Rating Depression Scale (HAM-D) score >/= 16 and who are fluent in English or Dutch.

Exclusion criteria

Presence of suicidal ideations, biopoloar, psychosis or primary eating disorder. Prior or resent use antidepressants including escitalopram, sertraline, venlafaxine XR. History of brain injury/blow resulting in loss of consciousness. evere impediment to vision, hearing and/or hand movement which may interfere with their ability to complete the protocol required test.

Outcome results