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SSRI/Clomipramine

Phase 3

Obsessive Compulsive Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Dec 18, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

SSRI/Clomipramine · 1 trial · 1 indication

Phase 3 1
NCT00254735Quetiapine Augmentation in Severe Obsessive Compulsive DisorderObsessive Compulsive Disorder
COMPLETED44 Analytics
PHASE3COMPLETED
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder
Obsessive Compulsive DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change of OCD symptoms from baseline to endpoint on the total Y-BOCS score.

Secondary Endpoints

Change of comorbid psychiatric symptoms and measures of quality of life from baseline to endpoint documented by different scales.
Evaluation of the safety and tolerability profile of quetiapine compared to placebo added to a baseline medication of SSRI/clomipramine.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
quetiapine fumarateDRUG -
SSRI/ClomipramineDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Signed informed consent, men and women aged ³18 to £65 years with diagnosis of OCD, at least 12 weeks of treatment with SSRI or clomipramine Exclusion Criteria: * Substance abuse or dependence, female patients who are pregnant, lactating or at risk of pregnancy, known intole...

Countries:Germany
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Frequently asked questions about SSRI/Clomipramine

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.