Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

NCT00751504 | Completed Phase 3 DMC

• 1 other identifier: D1443L00040
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Depression

Keywords

Quetiapine; Psychotic depression

Outcome Measures

Primary Outcomes (1)

• MADRS

  6 weeks

Secondary Outcomes (5)

• Clinical laboratory evaluation

  6 weeks

• Urinalysis

  6 weeks

• ECG

  6 weeks

• Physical and neurological examination

  6 weeks

• Vital signs

  6 weeks

Interventions

Quetiapine DRUG

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

Also known as: Seroquel Prolong

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy or lactation
• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

LWL University Hospital Bochum of the Ruhr-University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Related Publications (11)

• 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.

  PMID: 15022147 BACKGROUND

• 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.

  PMID: 15994719 BACKGROUND

• 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.

  PMID: 11436963 BACKGROUND

• 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.

  PMID: 10812533 BACKGROUND

• 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.

  PMID: 16889882 BACKGROUND

• 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.

  PMID: 15147108 BACKGROUND

• 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.

  PMID: 11436964 BACKGROUND

• 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.

  PMID: 12523876 BACKGROUND

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

  PMID: 10695160 BACKGROUND

• 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.

  PMID: 16648526 BACKGROUND

• 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.

  PMID: 10817103 BACKGROUND

MeSH Terms

Interventions

Quetiapine Fumarate

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Georg Juckel, M.D., Ph.D.

  LWL University Hospital Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Georg Juckel, LWL University Hospital Bochum

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

DE (1)