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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001217-17 | EudraCT Number |
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This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Quetiapine augmentation |
|
| Placebo | Placebo Comparator | "Placebo" augmentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine | Drug | Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HDRS) | after monotherapy and after augmentation |
| Measure | Description | Time Frame |
|---|---|---|
| Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI]) | after monotherapy and after augmentation | |
| Cognitive function | after monotherapy and after augmentation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florian Holsboer, MD, PhD | Max-Planck-Institute of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Max Planck Institute of Psychiatry | Munich | Bavaria | 80804 | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Quetiapine | Drug | Quetiapine up to 200 mg/d for four weeks |
|
|
| D001523 |
| Mental Disorders |
| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |