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Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

Primary Purpose

Psychotic Depression

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Depression focused on measuring Quetiapine, Psychotic depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LWL University Hospital Bochum of the Ruhr-University Bochum

Outcomes

Primary Outcome Measures

MADRS

Secondary Outcome Measures

Clinical laboratory evaluation
Urinalysis
ECG
Physical and neurological examination
Vital signs

Full Information

First Posted
September 11, 2008
Last Updated
January 23, 2013
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT00751504
Brief Title
Quetiapine in the Treatment of Psychotic Depression - a Pilot Study
Official Title
Quetiapine in the Treatment of Psychotic Depression - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Depression
Keywords
Quetiapine, Psychotic depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel Prolong
Intervention Description
Dosage form: tablets Dosage: between 300 mg/die and 600 mg/die Frequency: once daily Duration: 6 weeks
Primary Outcome Measure Information:
Title
MADRS
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Clinical laboratory evaluation
Time Frame
6 weeks
Title
Urinalysis
Time Frame
6 weeks
Title
ECG
Time Frame
6 weeks
Title
Physical and neurological examination
Time Frame
6 weeks
Title
Vital signs
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Juckel, M.D., Ph.D.
Organizational Affiliation
LWL University Hospital Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
LWL University Hospital Bochum of the Ruhr-University Bochum
City
Bochum
State/Province
NRW
ZIP/Postal Code
44791
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15022147
Citation
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. doi: 10.1002/da.10137.
Results Reference
background
PubMed Identifier
15994719
Citation
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. doi: 10.1176/appi.ajp.162.7.1351.
Results Reference
background
PubMed Identifier
11436963
Citation
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. doi: 10.1089/104454601750284144. No abstract available.
Results Reference
background
PubMed Identifier
10812533
Citation
Khouzam HR. Treatment of depressive mood in schizophrenia with the atypical antipsychotic quetiapine. Depress Anxiety. 2000;11(2):80-2. doi: 10.1002/(sici)1520-6394(2000)11:23.0.co;2-7.
Results Reference
background
PubMed Identifier
16889882
Citation
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. doi: 10.1016/j.pnpbp.2006.06.023. Epub 2006 Aug 4.
Results Reference
background
PubMed Identifier
15147108
Citation
Masan PS. Atypical antipsychotics in the treatment of affective symptoms: a review. Ann Clin Psychiatry. 2004 Jan-Mar;16(1):3-13. doi: 10.1080/10401230490281410.
Results Reference
background
PubMed Identifier
11436964
Citation
Padla D. Quetiapine resolves psychotic depression in an adolescent boy. J Child Adolesc Psychopharmacol. 2001 Summer;11(2):207-8. doi: 10.1089/104454601750284153. No abstract available.
Results Reference
background
PubMed Identifier
12523876
Citation
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. doi: 10.4088/jcp.v63n1211.
Results Reference
background
PubMed Identifier
10695160
Citation
Schulz SC. New antipsychotic medications: more than old wine and new bottles. Bull Menninger Clin. 2000 Winter;64(1):60-75.
Results Reference
background
PubMed Identifier
16648526
Citation
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. doi: 10.1192/bjp.bp.105.010470.
Results Reference
background
PubMed Identifier
10817103
Citation
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. doi: 10.4088/jcp.v61n0307.
Results Reference
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Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

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