Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

NCT00622245 | Terminated Phase 2

• 2 other identifiers: 12022A2007-002551-17
• Study Type: interventional
• Target: 166
• Locations: 17 countries
• Sites: 47

Brief Summary

This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

Conditions

Depression in Patients With Bipolar Disorder

Keywords

Depression; Bipolar disorder; Placebo-controlled; Double-blind; Multicenter; Clinical study; Mania

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms as measured by the change from baseline in total MADRS score

  8 weeks

Secondary Outcomes (1)

• HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations

  12 weeks

Study Arms (5)

Lu AA34893: 4 mg

EXPERIMENTAL

Drug: Lu AA34893

Lu AA34893: 12 mg

EXPERIMENTAL

Drug: Lu AA34893

Lu AA34893: 18 mg

EXPERIMENTAL

Drug: Lu AA34893

Quetiapine fumarate

OTHER

Active reference 300 mg

Drug: Quetiapine fumarate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lu AA34893 DRUG

per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period

Lu AA34893: 12 mg; Lu AA34893: 18 mg; Lu AA34893: 4 mg

Quetiapine fumarate DRUG

per oral, once daily, during 12 weeks, followed by a one-week tapering period

Quetiapine fumarate

Placebo DRUG

per oral doses, twice daily as capsules during 13 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current major depressive episode of bipolar I or bipolar II disorder, according to DSM-IV TR
• Moderate to severe depression
• History of at least one documented mania or hypomania episode
• Absence of current mania or hypomania

You may not qualify if:

• Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR
• Any substance disorder with the previous 6 months
• Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study
• ECT within 6 months before the study
• Female of childbearing potential and not using adequate contraception

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (50)

AU001

Brisbane, 4000, Australia

Location

AU003

Dandenong, 3175, Australia

Location

AU002

Malvern, 3144, Australia

Location

AT002

Vienna, 1010, Austria

Location

AT001

Vienna, 1090, Austria

Location

AT003

Vienna, 1090, Austria

Location

BE004

Brussels, 1180, Belgium

Location

BE003

Charleroi, 6000, Belgium

Location

BE002

Diest, 3290, Belgium

Location

BG004

Stara Zagora, 6000, Bulgaria

Location

CA303

London, N6A 4H1, Canada

Location

CA301

Montreal, H3M 3A9, Canada

Location

CA302

Orléans, K1C 1E9, Canada

Location

FR001

Clermont-Ferrand, 63003, France

Location

FR007

Orvault, 44700, France

Location

FR004

Paris, 75571, France

Location

FR002

Sartrouville, 78500, France

Location

DE004

Berlin, 10245, Germany

Location

DE003

Bochum, 44892, Germany

Location

DE002

Gelsenkirchen, 45879, Germany

Location

LT005

Kaunas, 50185, Lithuania

Location

LT003

Kaunas Region, 53136, Lithuania

Location

LT004

Klaipėda, 91251, Lithuania

Location

LT001

Vilnius, 10204, Lithuania

Location

LT002

Vilnius, 10204, Lithuania

Location

MY004

Klang, 43000, Malaysia

Location

MY005

Kota Kinabalu, 88815, Malaysia

Location

MY002

Kuala Lumpur, 59100, Malaysia

Location

PH002

Las Piñas, 1701, Philippines

Location

PH003

Mandaluyong, Philippines

Location

PH001

Mandaue City, 6014, Philippines

Location

PL002

Gdansk, 80-211, Poland

Location

RO001

Arad, 310022, Romania

Location

RO002

Bucharest, 41914, Romania

Location

RO003

Cluj-Napoca, 400012, Romania

Location

RO005

Craiova, 200260, Romania

Location

SK001

Bratislava, 82007, Slovakia

Location

SK002

Prešov, 081 81, Slovakia

Location

KR004

Inchon, 403-720, South Korea

Location

KR003

Jeonju, 561-712, South Korea

Location

KR005

Kyunggi-do, 431-720, South Korea

Location

KR002

Seoul, 110-744, South Korea

Location

SE006

Halmstad, 302 27, Sweden

Location

SE003

Lund, 223 61, Sweden

Location

SE005

Malmo, 211 22, Sweden

Location

SE002

Sollentuna, 191 35, Sweden

Location

SE001

Stockholm, 112 34, Sweden

Location

TW002

Taichung, 404, Taiwan

Location

UA003

Lviv, 79021, Ukraine

Location

GB001

Oxford, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Depression; Bipolar Disorder; Mania

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 27, 2010

Record last verified: 2010-09

Locations

LI (5); PL (1); TW (1); SL (2); FR (4); UA (1); MY (3); AU (3); BU (1); GB (1); DE (3); BE (3); SE (5); PH (3); RO (4); KR (4); CA (3)