Neurobiological Underpinnings of Placebo Response in Depression

NCT02562430 Phase 4 COMPLETED Results posted

In summary, the proposed research is novel with respect to design, technology, and its multi-level integration probing psychological and neurobiological constructs assumed to be crucially implicated in placebo response and has significant clinical and research implications for the future. Specifically, the future implications include: 1) identification of biomarkers and biosignatures of placebo responders, 2) new possibilities to understanding and manipulating the system, 3) possibly decreasing or eliminating a major confounder in clinical trials and drug development, and 4) refining treatments with novel drugs that decrease (in clinical trial) or increase (in clinical practice) the placebo response.

Details

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	76
Start date	2016-08
Completion	2022-08

Conditions

• Depression

Interventions

• Welbutrin XL
• Placebo

Primary outcomes

• HAM-D 32 — 8 weeks
  The HAM-D-32 (Hamilton Depression Rating Scale) scores can range between 0 and 124, with higher scores indicating more severe depression. Total score was reported here.

Countries

United States