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OpenTrials
Completed

NCT Number: NCT00206141

Seroquel in Bipolar Depression Versus Lithium

This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar Depression Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Kelowna, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.

Exclusion criteria

  • Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment,
  • History of non-response to an adequate treatment
  • Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
  • Pregnancy or lactation
  • Clinically relevant disease or clinical finding

Treatment and study plan

Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)

Drug

Primary outcomes

  1. The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Secondary outcomes

  1. MADRS total score response

  2. MADRS total score remission

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)

Important dates

Study start
2005
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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