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Psychotic DepressionPhase 3NCT00751504

Quetiapine in the Treatment of Psychotic Depression - a Pilot Study

A Phase 3 study testing Quetiapine in people with Psychotic Depression, run by Ruhr University of Bochum at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psychotic Depression
What is being tested?
Quetiapine
Type of treatment
Pill or oral medicine
How many people
16 participants
Where
1 siteGermany
Study dates
Sep 2008to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • LWL University Hospital Bochum of the Ruhr-University Bochum

    Bochum, North Rhine-Westphalia, 44791

Other trials in Germany

About this study

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.

Being tested
Quetiapine
Keywords
Quetiapine, Psychotic depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuetiapineDrug

    Also called Seroquel Prolong

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MADRS

    Measured: 6 weeks

Secondary outcomes (5)

  1. Clinical laboratory evaluation

    Measured: 6 weeks

  2. Urinalysis

    Measured: 6 weeks

  3. ECG

    Measured: 6 weeks

  4. Physical and neurological examination

    Measured: 6 weeks

  5. Vital signs

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00751504
Sponsor's protocol ID
D1443L00040
Status last verified
Jan 2013
First submitted
11 Sep 2008
Last updated
24 Jan 2013
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1002/da.10137.

    PubMed 15022147

  • 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.

    PubMed 15994719

  • 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.

    PubMed 11436963

  • 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.

    PubMed 10812533

  • 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.

    PubMed 16889882

  • 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.

    PubMed 15147108

  • 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.

    PubMed 11436964

  • 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.

    PubMed 12523876

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

    PubMed 10695160

  • 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.

    PubMed 16648526

  • 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.

    PubMed 10817103

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quetiapine in people with Psychotic Depression, run by Ruhr University of Bochum at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MADRS (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00751504, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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