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(12) Patent Application Publication (10) Pub. No.: US 2006/0039890 A1 Renshaw Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2006/0039890 A1 Renshaw Et Al US 20060039890A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0039890 A1 Renshaw et al. (43) Pub. Date: Feb. 23, 2006 (54) TREATMENT OF PSYCHOLOGICAL AND Publication Classification COGNITIVE DSORDERS USINGA CHOLESTEROL-LOWERINGAGENT IN (51) Int. Cl. COMBINATION WITH AN A6IK 3I/785 (2006.01) ANTDEPRESSANT A6IK 3.1/5415 (2006.01) A6IK 31/401 (2006.01) (76) Inventors: Perry F. Renshaw, Arlington, MA A6IK 3I/366 (2006.01) (US); Bruce M. Cohen, Lexington, MA A61K 31/192 (2006.01) (US) (52) U.S. Cl. ................... 424/78.16; 514/225.8; 514/423; 514/460; 514/548; 514/571 Correspondence Address: CLARK & ELBING LLP 101 FEDERAL STREET (57) ABSTRACT BOSTON, MA 02110 (US) (21) Appl. No.: 10/922,652 The present invention features compositions, kits, and meth ods for treating or reducing a cognitive or psychological (22) Filed: Aug. 20, 2004 disorder, Such as depression. US 2006/0039890 A1 Feb. 23, 2006 TREATMENT OF PSYCHOLOGICAL AND nosed, (b) administering to the patient a cholesterol-lower COGNITIVE DSORDERS USING A ing agent in combination with an antidepressant. The cho CHOLESTEROL-LOWERINGAGENT IN lesterol-lowering agent is administered in an amount COMBINATION WITH AN ANTIDEPRESSANT sufficient to lower the serum cholesterol of the patient and to increase brain membrane fluidity. The cholesterol-lowering FIELD OF THE INVENTION agent and the antidepressant work Synergistically to treat or reduce the Severity of the cognitive or psychological disor 0001. The invention relates to methods for treating psy der of the patient. chological and cognitive disorders by administering a cho lesterol-lowering agent in combination with an antidepres 0007. In an embodiment, the cholesterol-lowering agent Sant. and the antidepressant are administered in Separate formu lations. Alternatively, the cholesterol-lowering agent and the BACKGROUND antidepressant can be admixed together in a single formu lation. When administered in Separate formulations, the 0002 Cell membranes define the boundaries of cells and agents may be administered simultaneously or within 28 perform a variety of important cellular functions. One of days, 14 days, 7 days, or 1 day of each other. The choles their primary functions is to control the traffic of Substances terol-lowering agent and the antidepressant may or may not into and out of the cell. They also play a vital role in cell-cell be administered by the same route of administration (e.g., recognition, adhesion, communication, and Signaling. oral, intravenous, intramuscular, ophthalmic, topical, der 0003. The composition of a cell membrane determines its mal, Sub-cutaneous, and rectal). Optionally, the method can microscopic Structure, which in turn, affects Such parameters include an additional therapeutic regimen, Such as a lifestyle as membrane shape, permeability, and fluidity, as well as the change, including the adoption of a low-fat diet or low conformation and functionality of ion channels, enzymes, Sodium diet, StreSS management, physical exercise, reduc and receptors that are embedded within the membrane. tion in alcohol intake, and reduction in Smoking. Lipids and proteins are the primary components of cell 0008 For example, the patient being treated may be membranes, although carbohydrates may also be present. administered the cholesterol-lowering agent and the antide Phospholipids, Such as phosphatidylcholine and Sphingomy preSSant within 28 days of each other in amounts that elin, are the most abundant membrane lipids. Glycolipids together are Sufficient to treat or reduce the cognitive or and cholesterol are also prevalent in cell membranes. psychological disorder. 0004 Alterations in membrane lipid order and composi 0009. The cholesterol-lowering agent can be selected tion can have a profound impact on the physical and from the group consisting of a fibrate (e.g., clofibrate chemical properties of the membrane. For instance, changes (ATROMID-SCR)), a bile acid sequestrant (e.g., in the membrane's cholesterol-to-phospholipid ratio can cholestyramine and colestipol (COLESTID(R), and nicotinic lead to changes in membrane fluidity. Generally, an increase acid (niacin)), gemfibrozil (LOPID(R) and GEMCOR(R), in cholesterol content results in a decrease in membrane probucol (PANAVIRCR), and an HMG-CoA reductase inhibi fluidity, while a reduction in membrane cholesterol tends to tor (e.g., a statin, such as lovastatin (MEVACOROR), ceriv increase fluidity. Even relatively Small changes in membrane astatin (BAYCOLOR), fluvastatin (LESCOLOR), atorvastatin fluidity can induce considerable effects on membrane-linked (LIPITOR(R), pravastatin (PRAVACHOL(R), and simvasta functions, including ion transport, Signal recognition and tin (ZOCOR(R)). Preferably, the agent is atorvastatin or transduction, and the regulation of enzyme activities. Simvastatin. 0005 The relationship between cognitive and psycho logical disorders, Such as depression, and neurobiology is 0010. The antidepressant can be selected from the group extremely complex and ameliorating the cause or Symptoms consisting of a tricyclic antidepressant (TCA; e.g., imi of a cognitive or psychological disorder appears to involve pramine (TOFRANIL(R) and others), amitriptyline more than Simply increasing the availability of neurotrans (ELAVIL(R) and ENDEP(R), amoxapine, desipramine (NOR mitters. For example, patients receiving antidepressants, PRAMINE(R) and PERTOFRANE(R), nortriptyline (PAM which are drugs that alter the uptake of neurotransmitters, ELOR(R) and AVENTYL(R), trimipramine (SURMON Such as Serotonin and dopamine, by neurons in the brain, TIL(R), protriptyline (VIVACTIL(R), doxepin (ADAPIN(B), demonstrate an immediate increase in the availability of SINEQUANGR), clomipramine (ANAFRANIL(R), and various neurotransmitters, yet mood elevation can take maprotiline), a selective serotonin reuptake inhibitor (SSRI; months of pharmacotherapy, indicating an adaptation or e.g., fluoxetine (PROZAC(R), duloxetine (CYMBALTA(R), drug-induced plasticity is taking place. For Some patients, sertraline (ZOLOFTR), paroxetine (PAXIL(R) and antidepressant therapy does not relieve the Symptoms of SEROXAT(R), fluvoxamine (LUVOX(R), citalopram (CEL their cognitive or psychological disorder. Accordingly, there EXACR), escitalopram (LEXAPRO(R), and cipralex (ESCI is a need for improved therapies that provide relief to TALOPRAMCR), a serotonin and noradrenaline reuptake patients diagnosed with cognitive or psychological disor inhibitor (SNRI; e.g., milnacipran (IXEL(R), venlafaxine derS. (EFFEXOR(R), trazodone (DESYREL(R), mirtazapine (REMERONGR), nefazodone (SERZONE(R), reboxetine SUMMARY OF THE INVENTION (EDRONAX(R) and VESTRACR), and bupropion (WELL BUTRINGR), and a monoamine oxidase inhibitor (MAOI; 0006 The method of the present invention involves the e.g., phenelzine (NARDIL(R), tranylcypromine (PAR following steps: (a) performing a diagnostic test on the NATE(R), isocarboxazid (MARPLANGR), moclobemide patient to determine that the patient has a cognitive or (AUROIX(R) and MANERIX(R), brofaromine (CONSO psychological disorder and, if the patient has been So diag NAR(R), selegiline (ATAPRYL(R), DEPRENYL(R), and US 2006/0039890 A1 Feb. 23, 2006 ELDEPRYL(R), furazolidone (FUR.OXONE(R), isoniazid (RIFAMATE(R) and RIMACTANE(R/INH), pargyline (LANIAZID(R) and NYDRAZID(R), isoniazid rifampin (EUTONYL(R), procarbazine (MATULANE(R), (RIFAMATE(R) and RIMACTANE(R/INH), pargyline nomifensine (MERITAL(R), FA70, clorgyline, TV3326 (EUTONYL(R), procarbazine (MATULANE(R), (N-propargyl-(3R)-aminoindan-5-yl-ethyl methylcarbamte nomifensine (MERITAL(R), FA70, clorgyline, TV3326 hemitartate), and befloxatone) and instructions for its admin (N-propargyl-(3R)-aminoindan-5-yl-ethyl methylcarbamte istration, Separately or in admixture, with a cholesterol hemitartate), and befloxatone). lowering agent to a patient having or at risk of having a 0.011 The method of the invention may be used to treat cognitive or psychological disorder. or reduce the Severity of a variety of cognitive and psycho 0014. The invention also features a kit that includes a logical disorders, including cognitive and affective disor cholesterol-lowering agent Selected from a fibrate (e.g., ders, Such as depression (e.g., treatment-related depression), clofibrate (ATROMID-SCR)), a bile acid sequestrant (e.g., dysthymia, cyclothymia, bipolar disorder, Schizophrenia and cholestyramine and colestipol (COLESTID(R), and nicotinic Schizoaffective disorder, borderline personality disorder, acid (niacin)), gemfibrozil (LOPID(R) and GEMCOR(R), age-related memory loss, mild cognitive impairment, and probucol (PANAVIRCR), and an HMG-CoA reductase inhibi dementia of any etiology (e.g., Alzheimer Disease, Parkin tor (e.g., lovastatin (MEVACOROR), cerivastatin (BAY son's Disease, Creutzfeldt-Jakob Disease, Huntington's Dis COL(R), fluvastatin (LESCOLOR), atorvastatin (LIPITOR(R), ease, Pick's Disease, HIV, head trauma), panic disorder, pravastatin (PRAVACHOL(R), and simvastatin (ZOCOR(R)) Social phobia, bulimia, narcolepsy, attention deficit disorder and an antidepressant Selected from a tricyclic antidepres (ADD; with or without hyperactivity), obsessive-compul sant (TCA; e.g., imipramine (TOFRANIL(R) and others), Sive disorder, and Substance abuse disorders, including alco amitriptyline (ELAVIL(R) and ENDEP(R), amoxapine, hol, Stimulant, opiate, marijuana, Solvent, and nicotine abuse desipramine (NORPRAMINE(R) and PERTOFRANE(R), or dependence. The disorder may develop independent of a nortriptyline
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