NCT00224302

Brief Summary

We evaluate the efficacy and tolerability of duloxetine in the treatment of major depressive episodes during the course of psychotic disorders

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

June 4, 2008

Status Verified

September 1, 2005

Enrollment Period

2.3 years

First QC Date

September 15, 2005

Last Update Submit

June 3, 2008

Conditions

Psychotic Disorders

Keywords

Schizophrenia,schizoaffective disorder,major depressive episode,combination,duloxetine

Outcome Measures

Primary Outcomes (1)

  • CDSS, HAMD, PANSS, SANS

Secondary Outcomes (1)

  • PANSS, SANS, Serum levels of antipsychotic substances, Body weight, EPMS,Prolactin, blood pressure, heart rate

Interventions

DuloxetineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depressive episode, Severity: CDSS at least 8 points or HAMD at least 15 points, indication for the treatment with duloxetine
  • Lifetime diagnosis of a psychotic disorder (PANSS positive scale below 15 points)
  • Age between 18 and 65,
  • Informed consent

You may not qualify if:

  • No informed consent,
  • Contraindications with respect to duloxetine,
  • Gravidity or missing anticonceptive safety
  • Substance dependance (excluded nicotin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health, Department of Psychiatry,

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mathias Zink, MD

    Central Institute of Mental Health, Department of Psychiatry, Mannheim, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

August 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

June 4, 2008

Record last verified: 2005-09

Locations

DE(1)