Optimal Duration of Olanzapine Add-on Therapy in Major Depression

Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-controlled, Randomized, Phase III, Pilot Study in Parallel Group Design

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00568672

Acronym

OLA-D

Enrollment

Registered

2007-12-06

Start date

2007-10-31

Completion date

2008-04-30

Last updated

2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGOlanzapine

Olanzapine 5 mg / day for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* informed consent * age 18 - 80 * diagnosis of major depression according dsm-iv, unipolar course * Hamilton-Depression-Rating-Scale (17 item score) \> 18 prior to inclusion * 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Relapse Rate, Hamilton Depression Rating Scale (17 item version)	6 months

Secondary

Measure	Time frame
Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory	6 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026