NCT01971203 is a NA clinical trial of seroquel xr in Major Depressive Disorder, sponsored by Icahn School of Medicine at Mount Sinai.

Who is sponsoring NCT01971203?

NCT01971203 is sponsored by Icahn School of Medicine at Mount Sinai.

What drugs are being tested in NCT01971203?

Interventions in NCT01971203: seroquel xr, CBT.

What condition does NCT01971203 study?

NCT01971203 studies Major Depressive Disorder, Generalized Anxiety Disorder.

Is NCT01971203 still recruiting?

NCT01971203 is currently completed. Last updated 18 January 2018.

Are results published for NCT01971203?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-01-18 · How we verify

NCT01971203

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Double-blind, Randomized, Active Controlled Study of the Efficacy and Safety of Extended-release Quetiapine Fumarate (Seroquel XR) as Adjunctive Medication Therapy to Cognitive Behavioral Therapy in the Treat,Ent of Patients With Comorbid Major Depression and Generalized Anxiety Disorder

Completed NA Results posted Last updated 18 January 2018

What this trial tests

NA trial testing seroquel xr in Major Depressive Disorder in 62 participants. Completed in 1 June 2013.

Timeline

1 September 2009

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	62
Start date	1 September 2009
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	1 location across United States

Drugs / interventions tested

seroquel xr
CBT — full drug profile →

Conditions studied

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

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 18 to 65, 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.

MADRS
Time frame: baseline and 16 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.

Sponsor's own description

The primary objective of the study is to determine whether quetiapine extended-release in combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo in treating depressive and anxiety symptoms in patients with both major depression and generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about 45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which medication will be discussed. Both clinician administered and self-report measures will be used to compare groups before and after 16 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

NCT07094308 — The LIFT-ECHO Last Mile Project · NA · not yet recruiting
NCT07291427 — Chronic Subdural Hematoma Embolization With Detachable Coils · not yet recruiting
NCT07194187 — High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction · NA · not yet recruiting
NCT07260916 — Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation · NA · not yet recruiting
NCT07487948 — Safety and Biomarker Responses of Delgocitinib (JAK1,2,3/TYK2 Inhibitor) in Central Centrifugal Cicatricial Alopecia and · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01971203 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
Last refreshed: 18 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01971203.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing