Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8435 4 · 1 trial · 1 indication
SANS was a 25-item clinician-rated instrument for assessing the negative symptoms of schizophrenia. SANS 1-22 Composite Score consisted of the SANS 25 scale minus the last 3 questions (attention items). The remaining non-attention items (affective flattening, alogia, avolition-apathy, and anhedonia-asociality) comprised the SANS 1-22 Composite Score. For each item, symptom severity was rated on a 6-point scale, from 0=absent to 5=severe. The SANS 1-22 Composite Score had a total scoring range of 0 to 110. Higher scores indicated more impairment. The SANS 1-22 Composite Score was reported using data from the adjusted site rater. A negative change from baseline indicated an improvement in symptoms.
| Arm | Type | Description |
|---|---|---|
| MK-8435 (Org 25935) 8-16 mg per day | EXPERIMENTAL | Participants will be maintained on a stable dose of Second Generation Antipsychotic (SGA) and receive 4-8 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) can be titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose must remain stable after Day 42 for the remainder of the study. |
| MK-8435 (Org 25935) 24-32 mg per day | EXPERIMENTAL | Participants will be maintained on a stable dose of SGA and receive 12-16 mg MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. The dose of MK-8435 (Org 25935) can be titrated upward or downward within the specified dose range, as needed, up to Day 42 of the study. The dose must remain stable after Day 42 for the remainder of the study. |
| Placebo | PLACEBO_COMPARATOR | Participants will be maintained on a stable dose of SGA and receive matching placebo for MK-8435 (Org 25935) BID, in the morning and the evening, as add-on treatment for up to 87 days. |
| Name | Type | Description |
|---|---|---|
| MK-8435 (Org 25935) 4-8 mg | DRUG | Administered orally 2 times a day (BID) for a final concentration of 8-16 mg/day |
| Placebo | DRUG | Matching placebo for MK-8435 (Org 25935) administered orally BID |
| MK-8435 (Org 25935) 12-16 mg | DRUG | Administered orally BID for a final concentration of 24-32 mg/day |
Inclusion Criteria: * Is diagnosed with non-first episode schizophrenia meeting Diagnostic and Statistical Manual (Version IV) criteria * Is receiving stable treatment with one of the following SGA: aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone * Is in the non-acute phase of ill...
Top 15 of 16 competitors
MK-8435 4 is an investigational small molecule being studied as an adjuvant treatment for negative symptoms of schizophrenia. It was evaluated in a Phase 2 clinical trial in adults with schizophrenia. It is not approved for any indication and remains in clinical development.
MK-8435 4 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the Phase 2 trial of the compound in schizophrenia.
MK-8435 4 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug has not been approved by the FDA for any indication.
MK-8435 4 has been studied in one completed Phase 2 trial, NCT00725075, titled "Adjuvant Treatment With a Glycine Uptake Inhibitor in Participants With Negative Symptoms of Schizophrenia (P05695) (MK-8435-001)." The trial enrolled 215 participants, was randomized, double-blind, and placebo-controlled.