Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PD Dr. Christine Norra, MD, PhD, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00751504
First received: September 11, 2008
Last updated: January 23, 2013
Last verified: January 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:


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 ]

Enrollment: 16
Study Start Date: September 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Quetiapine
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
LWL University Hospital Bochum of the Ruhr-University Bochum
Bochum, NRW, Germany, 44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Georg Juckel, M.D., Ph.D. LWL University Hospital Bochum
  More Information

Publications:

Responsible Party: PD Dr. Christine Norra, MD, PhD, Prof. Dr. med. Georg Juckel, LWL University Hospital Bochum, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT00751504     History of Changes
Other Study ID Numbers: D1443L00040
Study First Received: September 11, 2008
Last Updated: January 23, 2013
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 August 25, 2014