Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Completed

CT.gov ID

NCT00751504

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Depression	Drug: Quetiapine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Outcome Measures

Primary Outcome Measures

MADRS [6 weeks]

Secondary Outcome Measures

Clinical laboratory evaluation [6 weeks]
Urinalysis [6 weeks]
ECG [6 weeks]
Physical and neurological examination [6 weeks]
Vital signs [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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