Clinical trial NCT00883493: Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Official title: A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bipolar Depression
Keywords: Acute bipolar depression
Lithium carbonate
quetiapine fumarate
MADRS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.


Eligibility criteria: Inclusion Criteria:

* Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed
* The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
* The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12

Exclusion Criteria:

* Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk
* Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
* Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Response Rate for MADRS.
timeFrame: baseline, week 8
measure: Hamilton Rating Scale for Depression (HAM-D) Total Score.
timeFrame: Baseline, 8 Weeks
measure: Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
timeFrame: baseline, 8 weeks
measure: Change in the Clinical Global Impression Severity (CGI-S) Score.
timeFrame: baseline, 8 weeks
measure: Change in Young Mania Rating Scale (YMRS) Total Score.
timeFrame: baseline, 8 weeks
measure: Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.
timeFrame: Baseline, 8 weeks
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.
timeFrame: baseline, 8 weeks
measure: Change in the Sheehan Disability Scale (SDS) Total Score.
timeFrame: baseline, 8 weeks
measure: Treatment Satisfaction Questionnaire (TSQ) Scores.
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Godoy Cruz
country: Argentina
facility: Research Site
state: Mendoza
city: Caba
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Aparecida de Goiania
country: Brazil
facility: Research Site
state: GO
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Bogota D.c
country: Colombia
facility: Research Site
state: Cundinamarca
city: Guatemala
country: Guatemala
facility: Research Site
state: Ciudad de Guatemala
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Durango
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Elazig
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Malatya
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
Study officials:
affiliation: Ege University Faculty of Medicine Psychiatry Department İzmir
name: Simavi Vahip, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: