NCT01256177

Brief Summary

The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

February 3, 2016

Completed
Last Updated

April 15, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

December 7, 2010

Results QC Date

October 31, 2013

Last Update Submit

March 18, 2016

Conditions

Bipolar Depression

Keywords

Bipolar DepressionMental disease,

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline

    Baseline to Week 8

Secondary Outcomes (8)

  • Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)

    8 weeks from baseline

  • Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)

    After 8 week of start of treatment

  • Change From Baseline to Each Assessment in MADRS Total Score

    Baseline to Week 8

  • Change From Baseline to Week 8 in HAM-D Total Scores

    Baseline to Week 8

  • Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)

    Baseline to Week 8

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Quetiapine Fumarate (SEROQUEL) Extended Release

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Quetiapine Fumarate (SEROQUEL) Extended ReleaseDRUG

Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.

1
PlaceboDRUG

Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Male and female patients, aged 18 to 65 years, inclusive.
  • Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x).
  • Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.
  • Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator

You may not qualify if:

  • Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder
  • Patients whose Young Mania Rating Scale (YMRS) total score \>12 at enrolment and randomisation.
  • Patients with \>8 mood episodes during the past 12 months at enrolment.
  • Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
  • Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.
  • Alcohol or other substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence.
  • Patients who, in the Investigator's judgment, pose a current serious suicidal or homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Baoding, China

Location

Research Site

Beijing, China

Location

Research Site

Changsha, China

Location

Research Site

Guangzhou, China

Location

Research Site

Hangzhou, China

Location

Research Site

Kunming, China

Location

Research Site

Nanjing, China

Location

Research Site

Shanghai, China

Location

Research Site

Shanxi, China

Location

Research Site

Tianjin, China

Location

Research Site

Wuhan, China

Location

Research Site

Xi'an, China

Location

Related Publications (1)

  • Li H, Gu N, Zhang H, Wang G, Tan Q, Yang F, Ning Y, Zhang H, Lu Z, Xu X, Shi J, Gao C, Li L, Zhang K, Tian H, Wang X, Li K, Li H, Xu Y, Xie S, Yu X. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2016 Apr;233(7):1289-97. doi: 10.1007/s00213-016-4215-z. Epub 2016 Feb 25.

    PMID: 26911380DERIVED

Related Links

MeSH Terms

Conditions

Bipolar DisorderMental Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dhaval Desai (MSD, Seroquel)
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com
+13028857643

Study Officials

  • Yuxin Gu Niufan, MD

    Shanghai Mental Health Center- Peking University sixth Hospital

    PRINCIPAL INVESTIGATOR

  • Dhaval Desai

    Wilmington, DE - Delaware

    STUDY DIRECTOR

  • Frank Hou

    Astrazeneca China

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 8, 2010

Study Start

December 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 15, 2016

Results First Posted

February 3, 2016

Record last verified: 2016-03

Locations

CN(12)