Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT01665950
Eligibility Criteria:
Inclusion:
* Age 18-65
* written informed consent
* meets Diagnostic and Statistical Manual - IV (DSM-IV) criteria (by Structured Clinical Interview for DSM-IV (SCID-I/P)) for bipolar I disorder, current episode depressed
* Montgomery-Asberg Depression Scale (MADRS) score of at least 20 (i.e., moderate depression) and no greater than 34 (i.e., severe depression) at screen and baseline visit
* Young Mania Rating Scale (YMRS) score \< 12 at screen and baseline visit
* currently treated with a lithium preparation (carbonate or citrate) at stable dose for at least 4 wks with level \>0.4 and \<1.0; and/or valproate at stable dose for at least 4 wks at level \>60 and \<110; and/or other atypical antipsychotic at stable dose for at least 4 weeks (at least minimum FDA-labeled dose).
Exclusion:
* Psychotic features in the current episode, as assessed by YMRS item #8\>6
* felt by the study clinician to require inpatient hospitalization for adequate management
* more than 3 failed pharmacologic interventions in the current major depressive episode, exclusive of primary mood stabilizer
* current substance use disorder other than nicotine, by SCID-I/P
* pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy)
* women who are breastfeeding
* serious suicide or homicide risk, as assessed by evaluating clinician
* other unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests
* patients who have taken an investigational psychotropic drug within the last 30 days
* patients receiving additional anticonvulsant, antipsychotic, or antidepressant within 1 week prior to study entry
* patients requiring continued treatment with excluded medications (see below).
Excluded medications: other statins, which could influence Wnt signaling; any other drug known to interact with simvastatin, including potent inhibitors/inducers of CYP3A4 such as itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, voriconazole, cyclosporine or danazol; gemfibrozil or other lipid-lowering drugs that can cause myopathy when given alone; amiodarone, ranolazine, verapamil, diltiazem, or amlodipine; niacin; digoxin; coumarin anticoagulants; colchicine; nefazodone; protease inhibitors including ritonavir, indinavir, nelfinavir, or saquinavir.
Allowed: benzodiazepines and sedative-hypnotic agents if dosage has been stable for 2 weeks prior to study entry; thyroid or estrogen replacement provided dosage has been stable for 1 month; antidepressants, antipsychotics, and anticonvulsants provided dosage has been stable for 1 week prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01665950
Study Brief:
Protocol Section:
NCT01665950