Relapse Rate of a Major Depressive EpisodePhase 3OLA-DNCT00568672
Optimal Duration of Olanzapine Add-on Therapy in Major Depression
A Phase 3 study testing Olanzapine in people with Relapse Rate of a Major Depressive Episode and Safety of Olanzapine in Subjects With Major Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Relapse Rate of a Major Depressive Episode, Safety of Olanzapine in Subjects With Major Depression
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Apr 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- highly effective contraceptive method in women
- no participation in other trial according to German Drug Laq
- normal liver function
Who cannot join
- 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
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- hospital treatment by legal order
- hepatic insufficiency
- severe neurological or medical disease
- adipositas permagna
- HIV-infection
- active viral hapatitis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin
Berlin, 14050
About this study
Official title: Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-controlled, Randomized, Phase III, Pilot Study in Parallel Group Design
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
- Being tested
- Olanzapine
- Keywords
- Major Depression, Olanzapine, add-on therapy, antidepressant, atypical antipsychotic
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called EU/1/96/022/002+019
Olanzapine 5 mg / day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Olanzapine 5 mg / day Receives: Drug: Olanzapine |
| 2 | Placebo comparator | Placebo Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Rate, Hamilton Depression Rating Scale (17 item version)
Measured: 6 months
Secondary outcomes (1)
Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startOct 2007 (estimated)
- Primary completionJan 2008 (estimated)
- Study completionApr 2008 (estimated)
Why it stopped: Withdrawn because of personal ressources before inclusion of the first patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse Rate of a Major Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Arnim Quante, Charite University, Berlin, Germany
- Investigators
- Ion Anghelescu, MD, Principal investigator, Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and PsychotherapyArnim Quante, MD, Principal investigator, Charite, University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568672
- Sponsor's protocol ID
- 2007-000512-82
- Acronym
- OLA-D
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2007
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-controlled, Randomized, Phase III, Pilot Study in Parallel Group Design
- ClinicalTrials.gov ID
- NCT00568672
- Acronym / sponsor ID
- OLA-D / 2007-000512-82
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn because of personal ressources before inclusion of the first patient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Oct 2007 (estimated)
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Apr 2008 (estimated)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: OlanzapineOlanzapine 5 mg / day |
| 2 | Placebo comparator | Drug: OlanzapinePlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineAlso: EU/1/96/022/002+019Olanzapine 5 mg / day for 6 months | Drug | 1, 2 |
Primary outcome
Relapse Rate, Hamilton Depression Rating Scale (17 item version)
Time frame: 6 months
1 secondary outcome
Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ion Anghelescu, MD principal investigator
Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
Arnim Quante, MD principal investigator
Charite, University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine in people with Relapse Rate of a Major Depressive Episode and Safety of Olanzapine in Subjects With Major Depression, run by Charite University, Berlin, Germany 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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 9 Feb 2023. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Relapse Rate, Hamilton Depression Rating Scale (17 item version) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2023.