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SSRI/Venlafaxine

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: May 23, 2012

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment688

FDA Designations

No designations recorded

Clinical trial landscape

SSRI/Venlafaxine · 1 trial · 2 indications

Phase 3 1
NCT00789854Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD PatientsMajor Depressive Disorder
COMPLETED688 Analytics
PHASE3COMPLETED
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
Major Depressive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)
6 weeks treatment

Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.

Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)
6 weeks of treatment

Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status.

Secondary Endpoints

Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients
6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure
6 weeks of treatment
Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure
6 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Add-on Quetiapine XR+SSRI/VenlafaxineACTIVE_COMPARATORSelective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od). From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline.
Add-on Lithium+SSRI/VenlafaxineACTIVE_COMPARATORSelective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od). From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline.
Monotherapy Quetiapine XRACTIVE_COMPARATORSwitch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)

Interventions

NameTypeDescription
Quetiapine XRDRUG300 mg once daily (od)
Lithium carbonateDRUG900 mg once daily (od)
SSRI/VenlafaxineDRUGSSRI - doses within label, Venlafaxine dose up to 225 mg/day
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites106

Inclusion Criteria: * Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode * Current episode of depression pre...

Countries:AustraliaAustriaBelgiumBulgariaDenmarkGermanyHungaryItalyPortugalRomaniaSlovakiaSpainUnited Kingdom
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Frequently asked questions about SSRI/Venlafaxine

What is SSRI/Clomipramine used for?

SSRI/Clomipramine is a small molecule being studied for use in Major Depressive Disorder and Obsessive Compulsive Disorder. It is an investigational therapy in Phase 3 clinical development for these psychiatric conditions. The drug is being developed by AstraZeneca PLC.

Who makes SSRI/Clomipramine?

SSRI/Clomipramine is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the drug for psychiatric indications including Major Depressive Disorder and Obsessive Compulsive Disorder.

What phase is SSRI/Clomipramine in?

SSRI/Clomipramine is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 3 trials for this drug have been completed, with studies conducted in multiple countries across Europe and Australia.

What clinical trials is SSRI/Clomipramine in?

SSRI/Clomipramine has been studied in two completed Phase 3 clinical trials. One trial, NCT00254735, evaluated the drug in patients with Obsessive Compulsive Disorder in Germany. Another trial, NCT00789854, compared the drug in patients with Major Depressive Disorder and Treatment Resistant Depression across multiple countries.

Is SSRI/Clomipramine the same as quetiapine?

SSRI/Clomipramine is being studied in clinical trials that also involve quetiapine. The trial NCT00254735 examined quetiapine augmentation in Obsessive Compulsive Disorder, and NCT00789854 compared quetiapine XR with lithium augmentation in treatment resistant depression. SSRI/Clomipramine itself is a separate drug being evaluated in these studies.