DepressionPhase 4NCT00253266
Venlafaxine Augmentation in Treatment Resistant Depression
A Phase 4 study testing Venlafaxine and Quetiapine in people with Depression, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial summary
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Venlafaxine and Quetiapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Aug 2014
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar I or II disorder without psychotic features
- Ages between 20 and 70 years
- Total score greater than 18 on the Hamilton Depression Rating Scale
- Documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode
Who cannot join
- Other psychiatric axis I disorders than those mentioned as Inclusion criteria
- Acute suicidality (Item 3 of the Hamilton Depression Rating Scale greater than 2)
- Drug or alcohol addiction
- Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
- Documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
- Functional kidney disorders
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- Untreated hypertension
- Acute treatment with thyroid hormone (less than 3 months)
- Pregnant or nursing patients
- Women of childbearing age without effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.
Read the detailed description
We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.
- Conditions
- Depression
- Being tested
- Venlafaxine, Quetiapine
- Keywords
- Treatment resistant depression, Augmentation, Pharmacogenetics
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Also called Trevilor retard
Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)
QuetiapineDrug
Also called Seroquel
Quetiapine up to 200 mg/d for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Quetiapine augmentation Receives: Drug: Venlafaxine; Drug: Quetiapine |
| Placebo | Placebo comparator | "Placebo" augmentation Receives: Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS)
Measured: after monotherapy and after augmentation
Secondary outcomes (2)
Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])
Measured: after monotherapy and after augmentation
Cognitive function
Measured: after monotherapy and after augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startApr 2008
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Holsboer, MD, PhD, Principal investigator, Max-Planck-Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253266
- Sponsor's protocol ID
- 01/2005
- Other IDs
- 2005-001217-17, 2005
- Status last verified
- Apr 2015
- First submitted
- 11 Nov 2005
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT00253266
- Acronym / sponsor ID
- 01/2005
- Conditions
- Depression
- Keywords
- Treatment resistant depression, Augmentation, Pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Nov 2005 (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.
This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.
Detailed description
We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.
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 |
|---|---|---|
| Verum | Experimental | Drug: Venlafaxine, Drug: QuetiapineQuetiapine augmentation |
| Placebo | Placebo comparator | Drug: Venlafaxine"Placebo" augmentation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar I or II disorder without psychotic features
- Ages between 20 and 70 years
- Total score greater than 18 on the Hamilton Depression Rating Scale
- Documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode
Key exclusion criteria (10 listed)
- Other psychiatric axis I disorders than those mentioned as Inclusion criteria
- Acute suicidality (Item 3 of the Hamilton Depression Rating Scale greater than 2)
- Drug or alcohol addiction
- Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
- Documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
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 |
|---|---|---|
| VenlafaxineAlso: Trevilor retardVenlafaxine XR up to 450 mg/d during the complete trial (8 weeks) | Drug | Placebo, Verum |
| QuetiapineAlso: SeroquelQuetiapine up to 200 mg/d for four weeks | Drug | Verum |
Primary outcome
Hamilton Depression Rating Scale (HDRS)
Time frame: after monotherapy and after augmentation
2 secondary outcomes
Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])
Time frame: after monotherapy and after augmentation
Cognitive function
Time frame: after monotherapy and after augmentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Florian Holsboer, MD, PhD principal investigator
Max-Planck-Institute of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venlafaxine and Quetiapine in people with Depression, run by Max-Planck-Institute of Psychiatry 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 4 inclusion and 10 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 8 Apr 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Hamilton Depression Rating Scale (HDRS) (time frame: after monotherapy and after augmentation). 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 8 Apr 2015.