---
title: Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
nct_id: NCT00883493
overall_status: COMPLETED
phase: PHASE3
sponsor: AstraZeneca
study_type: INTERVENTIONAL
primary_condition: Acute Bipolar Depression
countries: Argentina, Brazil, Chile, Colombia, Guatemala, Mexico, Peru, Turkey (Türkiye), Venezuela
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00883493.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00883493"
ct_last_update_post_date: 2012-07-11
last_seen_at: "2026-05-12T07:26:36.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT00883493](https://clinicaltrials.gov/study/NCT00883493)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 421
- **Lead Sponsor:** AstraZeneca
- **Conditions:** Acute Bipolar Depression
- **Start Date:** 2009-04
- **Completion Date:** 2011-03
- **CT.gov Last Update:** 2012-07-11

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Quetiapin fumarate XR** (EXPERIMENTAL) — Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
- **Quetiapin fumarate XR+Lithium carbonate** (EXPERIMENTAL) — Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.

## Interventions

- **Quetiapine fumarate XR** (DRUG) — Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
- **Lithium carbonate** (DRUG) — Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day

## Primary Outcomes

- **Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.** _(time frame: Baseline, 8 weeks)_ — The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks).

The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

## Secondary Outcomes

- **Response Rate for MADRS.** _(time frame: baseline, week 8)_
- **Hamilton Rating Scale for Depression (HAM-D) Total Score.** _(time frame: Baseline, 8 Weeks)_
- **Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score** _(time frame: baseline, 8 weeks)_
- **Change in the Clinical Global Impression Severity (CGI-S) Score.** _(time frame: baseline, 8 weeks)_
- **Change in Young Mania Rating Scale (YMRS) Total Score.** _(time frame: baseline, 8 weeks)_
- **Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.** _(time frame: Baseline, 8 weeks)_
- **Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.** _(time frame: baseline, 8 weeks)_
- **Change in the Sheehan Disability Scale (SDS) Total Score.** _(time frame: baseline, 8 weeks)_
- **Treatment Satisfaction Questionnaire (TSQ) Scores.** _(time frame: baseline, 8 weeks)_

## Locations (24)

- Research Site, La Plata, Buenos Aires, Argentina
- Research Site, Godoy Cruz, Mendoza Province, Argentina
- Research Site, Mendoza, Mendoza Province, Argentina
- Research Site, Caba, Argentina
- Research Site, Aparecida de Goiânia, Goiás, Brazil
- Research Site, Rio de Janeiro, Rio de Janeiro, Brazil
- Research Site, São Paulo, São Paulo, Brazil
- Research Site, Santiago, Chile, Chile
- Research Site, Medellín, Antioquia, Colombia
- Research Site, Bogota D.c, Cundinamarca, Colombia
- Research Site, Guatemala City, Ciudad de Guatemala, Guatemala
- Research Site, Monterrey, Nuevo León, Mexico
- Research Site, San Luis Potosí City, San Luis Potosí, Mexico
- Research Site, Durango, Mexico
- Research Site, Monterrey, Mexico
- Research Site, Lima, Lima Province, Peru
- Research Site, Ankara, Turkey, Turkey (Türkiye)
- Research Site, Elâzığ, Turkey, Turkey (Türkiye)
- Research Site, Istanbul, Turkey, Turkey (Türkiye)
- Research Site, Izmir, Turkey, Turkey (Türkiye)
- Research Site, Kocaeli, Turkey, Turkey (Türkiye)
- Research Site, Malatya, Turkey, Turkey (Türkiye)
- Research Site, Manisa, Turkey, Turkey (Türkiye)
- Research Site, Caracas, Venezuela

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.research site|la plata|buenos aires|argentina` — added _(2026-05-12)_
- `locations.research site|godoy cruz|mendoza province|argentina` — added _(2026-05-12)_
- `locations.research site|mendoza|mendoza province|argentina` — added _(2026-05-12)_
- `locations.research site|caba||argentina` — added _(2026-05-12)_
- `locations.research site|aparecida de goiânia|goiás|brazil` — added _(2026-05-12)_
- `locations.research site|rio de janeiro|rio de janeiro|brazil` — added _(2026-05-12)_
- `locations.research site|são paulo|são paulo|brazil` — added _(2026-05-12)_
- `locations.research site|santiago|chile|chile` — added _(2026-05-12)_
- `locations.research site|medellín|antioquia|colombia` — added _(2026-05-12)_
- `locations.research site|bogota d.c|cundinamarca|colombia` — added _(2026-05-12)_
- `locations.research site|guatemala city|ciudad de guatemala|guatemala` — added _(2026-05-12)_
- `locations.research site|monterrey|nuevo león|mexico` — added _(2026-05-12)_
- `locations.research site|san luis potosí city|san luis potosí|mexico` — added _(2026-05-12)_
- `locations.research site|durango||mexico` — added _(2026-05-12)_
- `locations.research site|monterrey||mexico` — added _(2026-05-12)_
- `locations.research site|lima|lima province|peru` — added _(2026-05-12)_
- `locations.research site|ankara|turkey|turkey (türkiye)` — added _(2026-05-12)_
- `locations.research site|elâzığ|turkey|turkey (türkiye)` — added _(2026-05-12)_
- `locations.research site|istanbul|turkey|turkey (türkiye)` — added _(2026-05-12)_
- `locations.research site|izmir|turkey|turkey (türkiye)` — added _(2026-05-12)_
- `locations.research site|kocaeli|turkey|turkey (türkiye)` — added _(2026-05-12)_
- `locations.research site|malatya|turkey|turkey (türkiye)` — added _(2026-05-12)_
- `locations.research site|manisa|turkey|turkey (türkiye)` — added _(2026-05-12)_
- `locations.research site|caracas||venezuela` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00883493.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00883493*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*