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Merck L-830982

Phase 2

Schizophrenia | Small molecule | Psychiatry |Merck & Company, Inc.|Last Updated: Oct 17, 2011

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Merck L-830982 · 1 trial · 1 indication

Phase 2 1
NCT00129441Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 StudySchizophrenia
COMPLETED16 Analytics
PHASE2COMPLETED
Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

N-back Task - Reaction Time
Week 4

The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.

N-back Task - Error Rate
Week 4

The N-back task is a sequential-letter memory task for which working memory load is varied, as the respondent must indicate when the current stimulus matches the one from 'n' steps earlier in the sequence. The dependent measure for the N-back task was performance in the 2-back condition, which provides the best index of performance and dorsolateral prefrontal cortex disturbances in subjects with schizophrenia.

AX Continuous Performance Test Task D-prime
Week 4

For the AX Continuous Performance Test, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.

Preparing to Overcome Prepotency (POP) Task - Reaction Time
Week 4

The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.

Preparing to Overcome Prepotency Task - Error Rate
Week 4

The POP task is a cued stimulus-response reversal paradigm that, similar to the AX Continuous Performance Test, requires increases in cognitive control through the maintenance and use of context information to overcome prepotent response tendencies.

Secondary Endpoints

Brief Psychiatric Rating Scale Total Score
Week 4
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score
Week 4
Repeatable Battery for the Assessment of Neuropsychological Status - Delayed Memory Subindex
Week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Merck L-830982EXPERIMENTAL -
Sugar pillPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Merck L-830982DRUGThe initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
PlaceboDRUGMedications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male participants * Between the ages of 18 and 50 * Meet diagnostic criteria for schizophrenia or schizoaffective disorder * Are clinically stable for a minimum of 3 months on current dose of medication * Are unemployed (i.e., work less than 20 hours per week at competitive em...

Countries:United States
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Frequently asked questions about Merck L-830982

What is Merck L-830982 used for?

Merck L-830982 is an investigational small molecule being developed for the treatment of schizophrenia. It is currently in Phase 2 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

How does Merck L-830982 work?

Merck L-830982 is a small molecule designed to modulate the GABA-A alpha2/3 receptor subtype. This target is believed to play a role in the neurobiological pathways associated with schizophrenia, and the drug aims to address symptoms by acting on this specific receptor.

Who is developing Merck L-830982?

Merck L-830982 is being developed by Merck & Company, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's potential as a treatment for schizophrenia.

What phase is Merck L-830982 in?

Merck L-830982 is in Phase 2 clinical development. It has completed one Phase 2 trial, and the drug remains investigational, meaning it is not yet approved for use outside of clinical research settings.

What clinical trials is Merck L-830982 in?

Merck L-830982 has been studied in a completed Phase 2 clinical trial registered as NCT00129441, titled "Gamma-Amino Butyric Acid (GABA)-A Alpha2/3 Study." This randomized, double-blind, placebo-controlled trial enrolled 16 male participants with schizophrenia in the United States.

Is Merck L-830982 the same as GABA-A alpha2/3?

Merck L-830982 is not the same as GABA-A alpha2/3; rather, GABA-A alpha2/3 is the molecular target that the drug acts on. The drug is designed to interact with this receptor subtype, which is a focus of its mechanism of action in treating schizophrenia.