Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients

NCT ID: NCT00789854

Last Updated: 2012-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 688 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-08-31

Brief Summary

The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.

Detailed Description

The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.

Conditions

Major Depressive Disorder; Treatment Resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Add-on Quetiapine XR+SSRI/Venlafaxine

Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od).

From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline.

Group Type: ACTIVE_COMPARATOR

Quetiapine XR

Intervention Type: DRUG

300 mg once daily (od)

SSRI/Venlafaxine

Intervention Type: DRUG

SSRI - doses within label, Venlafaxine dose up to 225 mg/day

Add-on Lithium+SSRI/Venlafaxine

Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od).

From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline.

Group Type: ACTIVE_COMPARATOR

Lithium carbonate

Intervention Type: DRUG

900 mg once daily (od)

SSRI/Venlafaxine

Intervention Type: DRUG

SSRI - doses within label, Venlafaxine dose up to 225 mg/day

Monotherapy Quetiapine XR

Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)

Group Type: ACTIVE_COMPARATOR

Quetiapine XR

Intervention Type: DRUG

300 mg once daily (od)

Interventions

Quetiapine XR

300 mg once daily (od)

Intervention Type: DRUG

Lithium carbonate

900 mg once daily (od)

Intervention Type: DRUG

SSRI/Venlafaxine

SSRI - doses within label, Venlafaxine dose up to 225 mg/day

Intervention Type: DRUG

Other Intervention Names

Seroquel XR; Quilonum Retard

Eligibility Criteria

Inclusion Criteria

• Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode
• Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months
• MADRS-Score ≥ 25 at enrolment and randomisation

Exclusion Criteria

• Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation
• Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
• Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Bauer, professor

Role: PRINCIPAL_INVESTIGATOR

Germany

Birgit Ekholm, PhD

Role: STUDY_DIRECTOR

AstraZeneca MC Sweden

Locations

Research Site

Garran, Australian Capital Territory, Australia

Research Site

Brisbane, Queensland, Australia

Research Site

Everton Park, Queensland, Australia

Research Site

Townsville, Queensland, Australia

Research Site

Gilberton, South Australia, Australia

Research Site

Clayton, Victoria, Australia

Research Site

Frankston, Victoria, Australia

Research Site

Heidelberg, Victoria, Australia

Research Site

Malvern, Victoria, Australia

Research Site

Prahran, Victoria, Australia

Research Site

Richmond, Victoria, Australia

Research Site

Graz, , Austria

Research Site

Klagenfurt, , Austria

Research Site

Salzburg, , Austria

Research Site

Vienna, , Austria

Research Site

Wels, , Austria

Research Site

Wiener Neustadt, , Austria

Research Site

Assebroek, Belgium, Belgium

Research Site

Diest, Belgium, Belgium

Research Site

Liège, Belgium, Belgium

Research Site

Tielt, , Belgium

Research Site

Cerova Koria Village, Veliko Tarnovo, Bulgaria

Research Site

Kardzhali, , Bulgaria

Research Site

Pazardzhik, , Bulgaria

Research Site

Pleven, , Bulgaria

Research Site

Rousse, , Bulgaria

Research Site

Sofia, , Bulgaria

Research Site

Varna, , Bulgaria

Research Site

Esbjerg N, , Denmark

Research Site

Frederiksberg, , Denmark

Research Site

Odense, , Denmark

Research Site

Aachen, , Germany

Research Site

Achim, , Germany

Research Site

Augsburg, , Germany

Research Site

Bad Homburg, , Germany

Research Site

Bad Honnef, , Germany

Research Site

Bad Saarow, , Germany

Research Site

Berlin, , Germany

Research Site

Bielefeld, , Germany

Research Site

Bochum, , Germany

Research Site

Butzbach, , Germany

Research Site

Chemnitz, , Germany

Research Site

Dresden, , Germany

Research Site

Düren, , Germany

Research Site

Düsseldorf, , Germany

Research Site

Ellwangen, , Germany

Research Site

Erbach im Odenwald, , Germany

Research Site

Gelsenkirchen, , Germany

Research Site

Gütersloh, , Germany

Research Site

Halle, , Germany

Research Site

Hattingen, , Germany

Research Site

Herborn, , Germany

Research Site

Kassel, , Germany

Research Site

Köthen, , Germany

Research Site

Neu-Isenburg, , Germany

Research Site

Neubrandenburg, , Germany

Research Site

Nuremberg, , Germany

Research Site

Oldenburg, , Germany

Research Site

Ostfildern, , Germany

Research Site

Schwerin, , Germany

Research Site

Stuttgart, , Germany

Research Site

Westerstede, , Germany

Research Site

Würzburg, , Germany

Research Site

Budapest, , Hungary

Research Site

Győr, , Hungary

Research Site

Gyula, , Hungary

Research Site

Nyíregyháza, , Hungary

Research Site

Brixen, BZ, Italy

Research Site

Bruneck, BZ, Italy

Research Site

Cagliari, CA, Italy

Research Site

Pisa, PI, Italy

Research Site

Roma, RM, Italy

Research Site

Bolzano, , Italy

Research Site

Catania, , Italy

Research Site

Napoli, , Italy

Research Site

Roma, , Italy

Research Site

Braga, , Portugal

Research Site

Coimbra, , Portugal

Research Site

Lisbon, , Portugal

Research Site

Santarém, , Portugal

Research Site

Galati, Galați County, Romania

Research Site

Bucharest, , Romania

Research Site

Craiova, , Romania

Research Site

Sibiu, , Romania

Research Site

Bratislava, , Slovakia

Research Site

Krupina, , Slovakia

Research Site

Levice, , Slovakia

Research Site

Liptovský Mikuláš, , Slovakia

Research Site

Michalovce Stranany, , Slovakia

Research Site

Prešov, , Slovakia

Research Site

Rožňava, , Slovakia

Research Site

Zilina-bytcica, , Slovakia

Research Site

Zlaté Moravce, , Slovakia

Research Site

Salamanca, Castille and León, Spain

Research Site

Zamora, Castille and León, Spain

Research Site

Barcelona, Catalonia, Spain

Research Site

Vigo, Galicia, Spain

Research Site

Langreo, Principality of Asturias, Spain

Research Site

Addlestone, Surrey, United Kingdom

Research Site

Winnick, Warrington, United Kingdom

Research Site

Horsham, West Sussex, United Kingdom

Research Site

Coventry, , United Kingdom

Research Site

Glasgow, , United Kingdom

Research Site

Harrow, , United Kingdom

Research Site

Hull, , United Kingdom

Research Site

Winsford, , United Kingdom

Countries

Australia; Austria; Belgium; Bulgaria; Denmark; Germany; Hungary; Italy; Portugal; Romania; Slovakia; Spain; United Kingdom

References

Bauer M, Dell'osso L, Kasper S, Pitchot W, Dencker Vansvik E, Kohler J, Jorgensen L, Montgomery SA. Extended-release quetiapine fumarate (quetiapine XR) monotherapy and quetiapine XR or lithium as add-on to antidepressants in patients with treatment-resistant major depressive disorder. J Affect Disord. 2013 Oct;151(1):209-19. doi: 10.1016/j.jad.2013.05.079. Epub 2013 Jun 27.

Reference Type: DERIVED

PMID: 23810357 (View on PubMed)

Other Identifiers

D1443L00044

Identifier Type: -

Identifier Source: org_study_id