Optimal Duration of Olanzapine Add-on Therapy in Major Depression

NCT00568672 | Withdrawn Phase 3 DMC

• 1 other identifier: 2007-000512-82
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.

Conditions

Relapse Rate of a Major Depressive Episode; Safety of Olanzapine in Subjects With Major Depression

Keywords

Major Depression; Olanzapine; add-on therapy; antidepressant; atypical antipsychotic

Outcome Measures

Primary Outcomes (1)

• Relapse Rate, Hamilton Depression Rating Scale (17 item version)

  6 months

Secondary Outcomes (1)

• Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Olanzapine 5 mg / day

Drug: Olanzapine

2

PLACEBO COMPARATOR

Placebo

Drug: Olanzapine

Interventions

Olanzapine DRUG

Olanzapine 5 mg / day for 6 months

Also known as: EU/1/96/022/002+019

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• age 18 - 80
• diagnosis of major depression according dsm-iv, unipolar course
• response towards therapy with antidepressant and olanzapine as defined \> 50 % reduction of HAMDD score
• negative pregancy test
• highly effective contraceptive method in women
• no participation in other trial according to German Drug Laq
• normal liver function

You may not qualify if:

• pregnancy, lactation
• depressive episode secondary to somatic disease or substance dependency
• contraindication for olanzapine
• treatment with interacting substances (CYP1A2 inhibitors or inductors)
• comorbidity according to DSM-IV, axis I
• denail of consent
• hospital treatment by legal order
• hepatic insufficiency
• severe neurological or medical disease
• adipositas permagna
• HIV-infection
• active viral hapatitis

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin

Berlin, 14050, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ion Anghelescu, MD

  Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

• Arnim Quante, MD

  Charite, University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Affective Disorders Section

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 6, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

DE (1)