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reboxetine monotherapy

Phase 2

Depressive Disorder, Major | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Jan 28, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment510

FDA Designations

No designations recorded

Clinical trial landscape

reboxetine monotherapy · 1 trial · 1 indication

Phase 2 1
NCT00636246A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.Depressive Disorder, Major
COMPLETED510 Analytics
PHASE2COMPLETED
A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
Depressive Disorder, Major
NCT00636246510
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Study Endpoints

Primary Endpoints

The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness.
visits 1-9

Secondary Endpoints

Change from Baseline in HAM-D (17-item) total score
Weeks 1, 2, 3, 5, 6, and 8
Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)
Weeks 5 and 8
The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.
Weeks 1, 2, 3, 5, 6, and 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sertraline/[S,S]-Reboxetine-satellite150/4EXPERIMENTAL -
Sertraline/[S,S]-Reboxetine-satellite150/6EXPERIMENTAL -
sertraline-satelliteACTIVE_COMPARATOR -
sertraline-mainACTIVE_COMPARATOR -
Sertraline/[S,S]-Reboxetine-satellite150/2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Sertraline/[S,S]-Reboxetine-mainEXPERIMENTAL -
[S,S]-reboxetine-mainACTIVE_COMPARATOR -

Interventions

NameTypeDescription
sertraline/[S,S]-reboxetineDRUGTablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg \[S,S\]-reboxetine for 5 and one half weeks.
sertralineDRUGTablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
PlaceboDRUGTablets, orally once per day for 8 weeks
[S,S]-reboxetine monotherapyDRUGTablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version ...

Countries:EstoniaRussia
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Frequently asked questions about reboxetine monotherapy

What is Reboxetine used for?

Reboxetine is an investigational small molecule being studied for the treatment of fibromyalgia, pain, and major depressive disorder. It is being developed by Pfizer, Inc. (NYSE: PFE). The drug has completed clinical trials in these indications, including a Phase 3 study in fibromyalgia.

What does Reboxetine target?

Reboxetine is a selective norepinephrine reuptake inhibitor, meaning it works by blocking the reuptake of norepinephrine in the brain, which increases its levels. This mechanism is thought to help modulate pain pathways and improve mood, which is why it is being studied for pain conditions and depression.

Who makes Reboxetine?

Reboxetine is being developed by Pfizer, Inc., a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer has conducted multiple clinical trials of Reboxetine for pain-related conditions and fibromyalgia.

What phase is Reboxetine in?

Reboxetine has completed Phase 3 clinical development for fibromyalgia, with a large study involving 1,129 patients. It has also completed Phase 2 trials for pain conditions. However, it is not FDA approved and remains an investigational drug, as no approval status has been reported.

What clinical trials is Reboxetine in?

Reboxetine has been studied in several completed trials, including NCT00143442 for postherpetic neuralgia, NCT00288652 for pain, NCT00357825 for fibromyalgia, and NCT00612170, a Phase 3 study in fibromyalgia. All trials are completed, with no active trials currently listed.

Is Reboxetine the same as [S,S]-Reboxetine?

Yes, Reboxetine is also known as [S,S]-Reboxetine, which is the specific enantiomer used in the clinical trials. The trials listed under NCT numbers refer to [S,S]-Reboxetine, and this form is the one being investigated for pain and fibromyalgia indications.