NCT00868374: MDD/GAD

Quetiapine XR Monotherapy or Adjunctive Therapy to Antidepressants in the Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder

Terminated Phase 3 Results posted Last updated 9 November 2016

What this trial tests

Phase 3 trial testing Quetiapine XR in Major Depressive Disorder in 23 participants. Terminated before completion.

Timeline

1 June 2008

Primary endpoint
1 October 2011

1 October 2011

Quick facts

Lead sponsor	Keming Gao
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	23
Start date	1 June 2008
Primary completion	1 October 2011
Estimated completion	1 October 2011
Sites	1 location across United States

Drugs / interventions tested

• Quetiapine XR
• Placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →
• Generalized Anxiety Disorder — all drugs for Generalized Anxiety Disorder →

Sponsor

Keming Gao

Who can join

Adults 18 to 70, any sex, with Major Depressive Disorder or Generalized Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)
  Time frame: Week 0 - Week 8
  The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25

Sponsor's own description

The primary objective is to test the hypothesis that quetiapine XR (Extended Release) monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients with major depressive disorder and comorbid generalized anxiety disorder, the improvement of the quality of sleep in patients with major depressive disorder and comorbid generalized anxiety disorder and the improvement of the quality of life in patients with major depressive disorder and comorbid generalized anxiety disorder.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.