Quetiapine in the Treatment of Psychotic Depression - a Pilot Study - Full Text View

Sponsor:	Ruhr University of Bochum
Information provided by:	Ruhr University of Bochum
ClinicalTrials.gov Identifier:	NCT00751504

Purpose

Atypical antipsychotics have been found not only to be beneficial in the treatment of psychotic disorders, but even for depressive symptoms in patients with schizophrenia. Remarkably, preliminary data suggest that the atypical antipsychotic quetiapine has antidepressive properties. Until now, there is limited knowledge concerning the efficacy of quetiapine in major depressive illness and especially in psychotic depression. In our own clinical practice, several patients with psychotic depression were successfully treated with quetiapine as add-on therapy or as monotherapy. On the background of that, the convincing effects of quetiapine in bipolar depression, single-case reports and pilot studies concerning its effectiveness in depressive mood states in psychotic disorders as well as our clinical experiences, it is to assume that a treatment with quetiapine over a 6 weeks period show similar effects in major depressive episode with psychotic features, i.e. psychotic depression. In this pilot study we plan to investigate 20 patients with psychotic features of depression under treatment with quetiapine.

Condition	Intervention	Phase
Psychotic Depression	Drug: Quetiapine	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Depression Mental Disorders Psychotic Disorders

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:

MADRS [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical laboratory evaluation [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Urinalysis [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Physical and neurological examination [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Dosage form: tablets Dosage: between 300 mg/die and 600 mg/die Frequency: once daily Duration: 6 weeks

Other Name: Seroquel Prolong

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

provision of written informed consent
diagnosis of depression with psychotic features by DSM-IV (296.23, 296.33)
females and males aged 18 to 65 years
female patients of childbearing potential must be using a reliable method of contraception and have a negative pregnancy test at enrollment
patients must be able to understand and comply with the requirements of the study
MADRS score above 20 points

Exclusion Criteria:

pregnancy or lactation
any DSM-IV Axis I disorder not defined in the inclusion criteria or not in full remission
patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
known intolerance or lack of response to quetiapine, as judged by the investigator
use of any cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment
use of any cytochrome P450 inducers in the 14 days preceding enrollment
thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range at enrollment
administration of a depot antipsychotic injection within one dosing interval before randomisation
substance or alcohol dependence at enrollment, as defined by DSM-IV
opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
risk of transmitting human immunodeficiency virus (HIV) or hepatitis B via blood or other body fluids
unstable or inadequately treated medical illness, as judged by the investigator
patients with diabetes mellitus (DM)
an absolute neutrophil count (ANC) < 1.5x10E9 per liter
history of idiopathic orthostatic hypotension, or condition that would predispose to
ECG considered to show clinically significant abnormalities at enrollment as determined by a cardiologist
involvement in the planning and conduct of the study
previous enrollment or randomisation of treatment in the present study
any serious and unstable somatic illness that, in the opinion of the investigator, would be negatively affects by the study medication
participation in another drug trial within 4 weeks prior to enrollment into this study
patients with unsufficient knowledge of the German language

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751504

Locations

Germany
LWL University Hospital Bochum of the Ruhr-University Bochum	Recruiting
Bochum, NRW, Germany, 44791
Contact: Georg Juckel, M.D., Ph.D. 00492345077202 georg.juckel@wkp-lwl.org
Principal Investigator: Georg Juckel, M.D., Ph.D.
Sub-Investigator: Hans-Jörg Assion, M.D.
Sub-Investigator: Nina Ansorge, M.D.
Sub-Investigator: Idun Uhl, M.D.
Sub-Investigator: Heinrich von Reventlow, M.Sc.

Sponsors and Collaborators

Ruhr University of Bochum

Investigators

Principal Investigator:

Georg Juckel, M.D., Ph.D.

LWL University Hospital Bochum

More Information

Publications:

Adson DE, Kushner MG, Eiben KM, Schulz SC. Preliminary experience with adjunctive quetiapine in patients receiving selective serotonin reuptake inhibitors. Depress Anxiety. 2004;19(2):121-6.

Calabrese JR, Keck PE Jr, Macfadden W, Minkwitz M, Ketter TA, Weisler RH, Cutler AJ, McCoy R, Wilson E, Mullen J. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry. 2005 Jul;162(7):1351-60.

Catapano-Friedman L. Effectiveness of quetiapine in the management of psychotic depression in an adolescent boy with bipolar disorder, mixed, with psychosis. J Child Adolesc Psychopharmacol. 2001 Summer;11(2):205-6. No abstract available.

Khouzam HR. Treatment of depressive mood in schizophrenia with the atypical antipsychotic quetiapine. Depress Anxiety. 2000;11(2):80-2.

Hidalgo J, Rico-Villademoros F, Calandre EP. An open-label study of quetiapine in the treatment of fibromyalgia. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):71-7. Epub 2006 Aug 4.

Masan PS. Atypical antipsychotics in the treatment of affective symptoms: a review. Ann Clin Psychiatry. 2004 Jan-Mar;16(1):3-13. Review.

Padla D. Quetiapine resolves psychotic depression in an adolescent boy. J Child Adolesc Psychopharmacol. 2001 Summer;11(2):207-8. No abstract available.

Sajatovic M, Mullen JA, Sweitzer DE. Efficacy of quetiapine and risperidone against depressive symptoms in outpatients with psychosis. J Clin Psychiatry. 2002 Dec;63(12):1156-63.

Schulz SC. New antipsychotic medications: more than old wine and new bottles. Bull Menninger Clin. 2000 Winter;64(1):60-75. Review.

Wijkstra J, Lijmer J, Balk FJ, Geddes JR, Nolen WA. Pharmacological treatment for unipolar psychotic depression: Systematic review and meta-analysis. Br J Psychiatry. 2006 May;188:410-5. Review.

Zarate CA Jr, Rothschild A, Fletcher KE, Madrid A, Zapatel J. Clinical predictors of acute response with quetiapine in psychotic mood disorders. J Clin Psychiatry. 2000 Mar;61(3):185-9.

Responsible Party:	Prof. Dr. med. Georg Juckel, LWL University Hospital Bochum
ClinicalTrials.gov Identifier:	NCT00751504 History of Changes
Other Study ID Numbers:	D1443L00040
Study First Received:	September 11, 2008
Last Updated:	September 11, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ruhr University of Bochum:

Quetiapine
Psychotic depression

Additional relevant MeSH terms:

Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Bipolar Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Affective Disorders, Psychotic

Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012