This list was graciously provided by JR Becker (jrbecker76@hotmail.com).
Some additions have been made by Shawn Thomas (shawn@neurotransmitter.net).
Please send additions or corrections to jrbecker76@hotmail.com
Information about recent drug approvals can be obtained from the FDA Center for Drug Evaluation and Research.
For information about drugs already marketed in the US, see Neurotransmitter.net's Drug Reference for FDA Approved Psychiatric Drugs.
A List of Drugs in Development for Neurodegenerative Diseases [PDF] compiled by Myoung-Ok Kwon and colleagues (2004) is available from the journal Neurodegenerative Diseases; 1(2-3):113–152.
Please support the NIMH's GenRED (Genetics of Recurrent Early-onset Depression) study, the largest psychiatric genetics study ever attempted.
Updated 12/11/05
Treatments for Depression and Anxiety
Drug Name Pharmacologic Action Company Indication Developmental Phase Links
EMSAM ® (selegiline) MAO-B inhibitor, weak MAO-A inhibitor [at higher doses]; administered transdermally Bristol-Myers Squibb, Somerset (Mylan/Watson)
Depression Approvable - the PDUFA date is Feb. 26 [6/16/05 press release] [2002 Clinical Trial]
Valdoxan (agomelatine, S-20098) 5-HT2C antagonist, 5-HT2B antagonist, melatonin M1/M2 receptor agonist Servier Depression, anxiety, sleep disorders Submitted in the European Union - Decision expected early to mid-2006 [Receptor activity] [Oct 2005 press release]
Gepirone ER 5-HT1A partial agonist Fabre-Kramer Depression, anxiety Amended NDA scheduled to be submitted 12/05 [June Press Release]
DVS-233 SR
(desvenlafaxine) Metabolite of Effexor ® (venlafaxine) Wyeth Depression, anxiety Pre-registration. NDA to be submitted in early 2006 [June Press Release]
SR 58611 beta-3-adrenoceptor agonist Sanofi-Aventis Depression, anxiety Phase III [SR 58611 is a selective beta-3-adrenoceptor agonist]
Saredutant (SR 48968) NK2 antagonist Sanofi-Aventis Depression, anxiety Phase III [Effects of SR 48968 on rodents]
PRX-00023 5-HT1A agonist, sigma receptor antagonist Predix Anxiety, ADHD, depression Phase III (still in phase II for depression)
Radafaxine, GW353162 Norepinephrine reuptake inhibitor and weak dopamine reuptake inhibitor (metabolite of bupropion) GSK Depression, obesity Phase III - to begin in 2006
GW372475, NS2359 Dopamine, serotonin, and norepinephrine, reuptake inhibitor GSK, NeuroSearch Depression Phase II
Ocinaplon GABA-A modulator DOV Anxiety Phase III - Discontinued [DOV's info]
DOV 216,303 DA/NE/5-HT reuptake inhibitor DOV/Merck Depression, anxiety Phase II - complete [DOV's info]
Nemifitide
(INN 00835) Pentapeptide analog of melanocyte-inhibiting factor (MIF-1) administered intravenously (mechanism unknown) Innapharma Depression Phase II [Innapharma's info] [Antidepressant-like effects of a novel pentapeptide, nemifitide, in an animal model of depression] [MIF-1 may regulate ACTH secretion]
Miraxion, LAX-101 "Purified" Omega-3 [EPA] Amarin Huntington's Disease, Depression Phase II
ORG 34517/34850 GR antagonist Organon Depression Phase II
CP-122,721 NK1 antagonist Pfizer Depression, anxiety Phase II [Effects of CP-122,721 on gerbils]
VPI-013, OPC-14523 5-HT1A agonist, sigma receptor agonist [also a serotonin reuptake inhibitor at higher doses] Vela
Depression Phase II [OPC-14523 responses in rats]
Vestipitant, GW597599 NK1 antagonist GSK Depression, anxiety Phase II
YKP-10A, R228060 Phenylalanine derivative Janssen (Johnson & Johnson)/SK Pharmaceuticals Depression Phase II [First Phase II Study]
ORG 4420 NaSSA (noradrenergic/specific serotonergic antidepressant) Organon Sleep disorders, depression, anxiety Phase II
Elzasonan, CP-448,187 5-HT1B and 5-HT1D receptor antagonist Pfizer Depression, anxiety Phase II
MN-305 5-HT1A partial agonist MediciNova Anxiety Phase II
Vilazodone 5-HT1A partial agonist, serotonin reuptake inhibitor Genaissance Pharmaceuticals Depression, anxiety Phase II [9/04 press release]
GW679769 NK1 antagonist GSK Depression, anxiety Phase II
LY354740 mGluR2, mGluR3 agonist Eli Lilly Anxiety Phase II [LY354740 is a nonsedative anxiolytic]
XBD173 Peripheral mitochondrial benzodiazepine receptor agonist Novartis Anxiety Phase II
R-tofisopam R-isomer of racemic tofisopam (a 2,3-benzodiazepine) Vela Anxiety, IBS Phase I
DOV 21, 947 Dopamine, serotonin, and norepinephrine, reuptake inhibitor DOV/Merck Depression, ADHD, RLS Phase I [Antidepressant-like actions of DOV 21,947]
GW823296 NK1 antagonist GSK Depression, anxiety Phase I
PRE703 MgluR agonist Prescient Anxiety Phase I
SSR149415 V1B antagonist Sanofi-Aventis Depression, anxiety, hyperphagia Phase I [SSR149415 review]
Delucemine, NPS 1506 NMDA antagonist NPS Depression, stroke Phase I [NPS-1506 provides neuroprotection]
Lu AA21004 5-HT reputake inhibitor Lundbeck Depression, anxiety Phase I
SEP-225289 DA/NE/5-HT reuptake inhibitor Sepracor Depression, anxiety Phase I
DMP904 CRF1 antagonist Bristol-Myers Squibb Depression, anxiety Phase I [DMP904 has an anxiolytic effect in rats]
DMP696 CRF1 antagonist Bristol-Myers Squibb Depression, anxiety Phase I [DMP696 is highly selective and potent]
CP-316,311 CRF1 antagonist Pfizer Depression, anxiety Phase I
GW876008 CRF1 antagonist Neurocrine/GSK Depression, anxiety Phase I
ONO-2333Ms CRF1 antagonist Ono Pharmaceuticals Depression, anxiety Phase I
JNJ-19567470 or TS-041 CRF1 antagonist Janssen (Johnson & Johnson), Taisho Depression, anxiety Phase I [Taisho's press release]
SSR 125543 CRF1 antagonist Sanofi-Aventis Depression, anxiety, hyperphagia Phase I
ND7001 PDE2 inhibitor Neuro3d Depression, anxiety Phase I
YKP3089 Undisclosed mechanism of action SK Pharmaceuticals Anxiety Phase I
R1576 GPCR modulator Roche Depression, anxiety Phase I
-- CRF1 antagonist Neurogen Depression, anxiety Pre-clinical
SSR 126374 CRF1 antagonist Sanofi-Aventis Depression, anxiety, hyperphagia Pre-clinical
SSR 411298 FAAH (fatty acid amide hydrolase) inhibitor Sanofi-Aventis Depression, anxiety, hyperphagia Pre-clinical
SSR 101010 FAAH (fatty acid amide hydrolase) inhibitor Sanofi-Aventis Depression, anxiety, hyperphagia Pre-clinical
SSR 241586 NK2 and NK3 receptor antagonist Sanofi-Aventis Depression, anxiety, IBS, COPD Pre-clinical
CRF1 antagonist (backup) CRF1 antagonist GSK/Neurocrine Depression, anxiety Pre-clinical
AZD2327 AstraZeneca Anxiety Pre-clinical
R1661 Roche Anxiety Pre-clinical
SAR 102279 NK2 receptor antagonist Sanofi-Aventis Depression, anxiety Pre-clinical
YKP581 Undisclosed mechanism of action SK Pharmaceuticals (J & J) Depression Pre-clinical
Treatments for Sleep Disorders
Drug Name Pharmacologic Action Company Indication Developmental Phase Links
Rozerem ® (ramelteon, TAK-375) Melatonin MT1, MT2 receptor agonist Takeda Insomnia characterized by difficulty with sleep onset Approved, product currently available in most pharmacies [Product website]
Ambien CR ® (Zolpidem MR) sustained-release version GABA-A modulator Sanofi-Aventis Sleep disorders Approved, product currently available in most pharmacies [Product website]
Xyrem ® (sodium oxybate) Oral form of gamma-hydroxybutyrate (GHB) Orphan Medical Excessive daytime sleepiness in narcolepsy Approved, product currently available in most pharmacies [Submission press release for narcolepsy]
Indiplon IR; Indiplon MR GABA-A modulator (at BZ1 sites) Neurocrine/DOV Sleep disorders NDAs submitted. Feb. 15, 2006 PDUFA date for IR capsules and March 27, 2006 PDUFA date for MR tablets [Neurocrine's info]
Gaboxadol (aka THIP) GABA-A agonist (gaboxadol acts as a full or partial agonist depending on the subunit composition of the GABA-A receptors that it binds to) Lundbeck, Merck Sleep disorders Phase III [Full/Partial agonism] [Gaboxadol does not produce tolerance to its sleep inducing effects]
Eplivanserin, SR 46349 5-HT2A receptor antagonist Sanofi-Aventis Sleep disorders Phase II - complete [phase III to begin in 2006]
VEC-162 Melatonin receptor agonist Vanda Pharmaceuticals Sleep disorders, depression Phase II - complete [Vanda's info]
Zaleplon (Sonata ®) extended-release GABA-A modulator King Pharmaceuticals (Mylan) Sleep disorders Phase II
PD-6735 Melatonin receptor agonist Phase 2 Discovery Sleep Disorders Phase II
ORG 50081 NaSSA (noradrenergic/specific serotonergic antidepressant) Organon Sleep disorders, hot flashes Phase II
M-100907 5-HT2A antagonist Sanofi-Aventis Sleep disorders Phase II [M-100907 review]
PD-200,390 Voltage-gated calcium channel alpha(2)delta subunit modulator Pfizer Sleep disorders Phase II
NG2-73 GABA-A modulator Neurogen Sleep disorders Phase I
Pruvanserin, EMD 281014 5-HT2A antagonist Eli Lilly Sleep disorders Phase I
APD125 5-HT2A inverse agonist Arena Sleep disorders Phase I
GW649868 Orexin antagonist GSK Sleep disorders Late-stage Pre-clinical [GSK presentation (PDF)]
AVE 8488 5-HT2A antagonist Sanofi-Aventis Sleep disorders Late-stage Pre-clinical
Treatments for Psychosis/Bipolar Disorder
Drug Name Pharmacologic Action Company Indication Developmental Phase Links
Paliperidone IM, ER Full 5-HT2/partial D2 antagonist with high affinity for 5-HT7 receptors. Active metabolite of Risperdal® Johnson & Johnson Psychosis NDA Submitted [Nov. 30 press release]
Corlux ® (AKA mifepristone or RU-486) Glucocorticoid receptor type II (GRII) antagonist, progesterone receptor antagonist Corcept Psychosis, depression Phase III, granted fast track status by FDA [Corcept's info]
Bifeprunox (DU-127090) Partial agonist at dopamine D2 and serotonin 5-HT1A receptors Solvay, Wyeth Psychosis Phase III (additional trials were recently announced) [Oct 2005 presentation]
Asenapine (ORG 5222) 5-HT2 antagonist, D2 partial agonist Organon, Pfizer Psychosis Phase III [Organon 2003 press release]
Zomaril (Iloperidone) Selective DA/NE/5-HT antagonist Vanda Pharmaceuticals Psychosis Phase III
Ocaperidone D2/5-HT2 antagonist Neuro3d, Janssen Psychosis Phase III Drug profile
SLV 308 D2 partial agonist, 5-HT1A agonist Solvay Psychosis, Parkinson's disease Phase III
LIC477D (licarbazepine) Voltage-gated sodium channel inhibitor Novartis Psychosis Phase III
ORG 34517/34850 Glucocorticoid receptor type II (GRII) antagonist Organon Depression, psychosis Phase II
ORG 24448 AMPA modulator Organon/Cortex Psychosis Phase II
ACP-103 Serotonin 5-HT2A receptor inverse agonist, dopamine D2/D3 receptor partial agonist, acetylcholine M1 receptor agonist Acadia Antipsychotic-induced side effects, Parkinson's disease Phase II [9/2004 press release]
ACP-104 Metabolite of clozapine Acadia Psychosis Phase II
RG2133 (triacetyluridine) Prodrug of uridine Repligen Bipolar disorder Phase II [Repligen's info] [10/21/05 press release]
Lonasen (blonanserin) D2, 5-HT2A antagonist Dainippon Pharmaceuticals Psychosis Phase II
Mirapex ® (pramipexole) Dopamine D2, D3 receptor agonist Boehringer-Ingelheim Bipolar Disorder Phase II
Lu-35-138 D4/5-HT antagonist Lundbeck Psychosis Phase II
Lurasidone (SM 13496) D2, 5-HT2A antagonist Merck, Sumitomo
Psychosis Phase II
Talnetant (SB-223412) NK-3 antagonist GSK Psychosis, IBS, overactive bladder Phase II
RG1068, secretin Endogenous pancreatic hormone Repligen Psychosis, autism, anxiety Phase II
SLV 310,313 5-HT2A antagonist Solvay Psychosis Phase II
SSR 181507 D2/5-HT2 antagonist Sanofi-Aventis Psychosis Phase I
ABT-089 Nicotinic acetylcholine receptor agonist Abbott Laboratories Psychosis Phase I
GW742457 5-HT6 antagonist GSK Psychosis, Alzheimer's disease Phase I
GW773812 D2, 5-HT antagonist GSK Psychosis Phase I
TC-1827 Selective alpha4beta2 nicotinic acetylcholine receptor agonist Targacept Cognitive impairment associated with schizophrenia Phase I
SSR 146977 NK3 antagonist Sanofi-Aventis Psychosis Phase I
SSR 125047 Sigma receptor antagonist Sanofi-Aventis Psychosis Phase I
AVE 1625 CB1 antagonist Sanofi-Aventis Psychosis Phase I
JNJ-17305600 GLYT1 inhibitor Johnson & Johnson Psychosis Phase I
PNU 170413 Pfizer Psychosis Phase I
MEM 3454 alpha7 nicotinic acetylcholine receptor partial agonist Memory Pharm./ Roche Psychosis Late-stage Preclinical [Memory's drug profile]
PDE10A PDE10A inhibitor Memory Pharm./ Roche Psychosis Late-stage Preclinical
SSR 504734 GLYT1 (Type 1 glycine transporter) inhibitor Sanofi-Aventis Psychosis Late-stage Preclinical
SSR 125047 GLYT1 (Type 1 glycine transporter) inhibitor Sanofi-Aventis Psychosis Late-stage Preclinical
Treatments for Attention Deficit Hyperactivity Disorder (ADHD)
Drug Name Pharmacologic Action Company Indication Developmental Phase Links
Sparlon ® (modafinil) aka Provigil ® Alpha-1-adrenoceptor agonist, dopamine reuptake inhibitor Cephalon, Johnson & Johnson ADHD Approvable
Daytrana ®
(methylphenidate transdermal system) Dopamine reuptake inhibitor, weak norepinephrine reuptake inhibitor Shire Pharmaceuticals/Noven Pharmaceuticals
ADHD The FDA advisory panel has backed approval. PDUFA date is 12/28/05 [Shire 7/26/05 press release]
NRP104
NRP104 is lysine linked to d-amphetamine single salt. Until it is metabolized in the gastrointestinal tract, NRP104 is inactive. At plasmalemmal catecholamine transporters, amphetamine indirectly increases the efflux of cytosolic catecholamines so that they are released into the synaptic cleft (1). The drug causes the release of norepinephrine more potently than it causes the release of dopamine; it is much less effective as a serotonin releasing agent (1) The drug also directly inhibits norepinephrine and dopamine reuptake at higher concentrations (1). Amphetamine- induced activation of protein kinase C (PKC) beta(II) is responsible for the drug's effect on dopamine efflux (2). Na+ is cotransported with amphetamine as it enters neurons via catecholamine transporters; amphetamine-induced increases in intracellular Na+ may stimulate Na+/Ca2+ antiporters, resulting in an influx of Ca2+ into the cytosol (3). The activity of a Ca2+ dependent enzyme, phospholipase C (PLC), is increased by amphetamine, and PLC may be responsible for the increase in PKC beta(II) activity associated with amphetamine (3). Intracellular dopamine is also required for amphetamine- induced increases in PKC activity (3). Amphetamine increases the activity of phospholipase A2 (PLA2), perhaps by increasing intracellular pH (3). Low PLA2 activity may increase the activation of PKC, while high PLA2 activity may decrease the activation of PKC by amphetamine (3).
Amphetamine, a weak base, increases cytosolic dopamine and norepinephrine through two mechanisms. First, amphetamine inhibits vesicular sequestration of dopamine and norepinephrine into vesicles by directly interacting with vesicular monoamine transporter-2 (VMAT-2) (4). Second, amphetamine decreases VMAT-2 activity by reducing the pH gradients that drive monoamine uptake into vesicles (5).
At higher concentrations, amphetamine may act as a competitive antagonist at NMDA receptors (6). In addition, the drug is an agonist at TA1, a trace amine receptor (7).
Shire Pharmaceuticals/ New River Pharmaceuticals ADHD Pre-registration. Filing expected in the fourth quarter of 2005. [New River compound info]
SPD-503 (guanfacine) Alpha-2-adrenoceptor agonist Shire Pharmaceuticals ADHD Pre-registration. Filing expected in the first quarter of 2006.
SPD-465 (longer acting Adderall XR ®) Long-acting amphetamine product (see above for amphetamine's mechanism of action) Shire Pharmaceuticals ADHD Phase III
NS-2359 DA/NE/5-HT reuptake inhibitor NeuroSearch ADHD Phase II
SGS-742 GABA-B receptor antagonist Saegis/ Novartis Adult ADHD Phase II
ABT-089 Nicotinic acetylycholine receptor modulator (agonist, partial agonist, or antagonist depending on the subtype) Abbott ADHD Phase II
CX-717 AMPA receptor modulator Cortex Pharmaceuticals ADHD Phase II [Cortex 7/28/05 press release]
Altropane Highly selective dopamine transporter radioligand Boston Life Sciences ADHD (diagnosis) Phase II
DOV-102,677 DA/NE/5-HT reuptake inhibitor (with preferential action on the dopamine transporter) DOV Pharmaceuticals ADHD Phase I
SON-216 (bifemelane) Sosei ADHD
DAR-0300 ADHD
PGI-256 ADHD
PGI-415 ADHD
SPD-483 Shire Pharmaceuticals ADHD Preclinical
Recently Discontinued Drugs
Drug Name Pharmacologic Action Company Indication
ND1251 PDE4 inhibitor Neuro3d Depression
NGD 96-3 GABA-A modulator Neurogen Sleep disorders
AAG561 CRF1 antagonist Novartis Depression
APPENDIX 1
Terms glossary
Phase I:
Phase I includes the initial introduction of an investigational new drug into humans. Phase I studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase I, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase II studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80.
Phase II:
Phase II includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase II studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.
Phase III:
A phase III trial frequently compares a new treatment to a standard treatment or to no treatment, and treatment allocation may be randomly assigned and the data masked. These studies usually involve a large number of participants followed for longer periods of treatment exposure. Phase III studies are expanded controlled and uncontrolled trials. Phase III studies usually include from several hundred to several thousand subjects.
NDA: New Drug Application. NDA refers to the data that the drug company submits to the FDA at the time of the drug's application filing.
Approvable: Term giving to a drug's approval status by the FDA. Before the drug can be launched, the company has to fulfill ongoing clinical and manufacturing concerns brought up by the FDA.
REFERENCES
1. Rothman RB, Baumann MH, Dersch CM, Romero DV, Rice KC, Carroll FI, Partilla JS.
Amphetamine-type central nervous system stimulants release norepinephrine more potently than they release dopamine and serotonin.
Synapse 2001 Jan;39(1):32-41 [Abstract]
2. Johnson LA, Guptaroy B, Lund D, Shamban S, Gnegy ME.
Regulation of amphetamine-stimulated dopamine efflux by protein kinase C beta.
J Biol Chem. 2005 Mar 25;280(12):10914-9. [Abstract]
3. Giambalvo CT.
Mechanisms underlying the effects of amphetamine on particulate PKC activity.
Synapse. 2004 Feb;51(2):128-39. [Abstract]
4. Erickson JD, Schafer MK, Bonner TI, Eiden LE, Weihe E.
Distinct pharmacological properties and distribution in neurons and endocrine cells of two isoforms of the human vesicular monoamine transporter.
Proc Natl Acad Sci U S A. 1996 May 14;93(10):5166-71. [Full Text]
5. Sulzer D, Rayport S.
Amphetamine and other psychostimulants reduce pH gradients in midbrain dopaminergic neurons and chromaffin granules: a mechanism of action.
Neuron. 1990 Dec;5(6):797-808. [Abstract]
6. Yeh GC, Chen JC, Tsai HC, Wu HH, Lin CY, Hsu PC, Peng YC.
Amphetamine inhibits the N-methyl-D-aspartate receptor-mediated responses by directly interacting with the receptor/channel complex.
J Pharmacol Exp Ther. 2002 Mar;300(3):1008-16. [Full Text]
7. Miller GM, Verrico CD, Jassen A, Konar M, Yang H, Panas H, Bahn M, Johnson R, Madras BK.
Primate trace amine receptor 1 modulation by the dopamine transporter.
J Pharmacol Exp Ther. 2005 Jun;313(3):983-94. [Abstract]
MADISON, N.J., Dec. 22 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for desvenlafaxine extended release (DVS-233) for the treatment of major depressive disorder (MDD). Desvenlafaxine extended release represents Wyeth's ongoing commitment to research and development of new antidepressant therapies. The new compound was discovered and developed by Wyeth Research.
The clinical development program for major depressive disorder supporting the NDA investigated desvenlafaxine extended release, a serotonin/norepinephrine reuptake inhibitor (SNRI), in patients with a broad range of symptoms associated with depression, including both emotional and somatic symptoms.
"We know from clinical studies as well as clinical practice that there remain significant unmet needs in treating depressed patients," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth. "If approved, desvenlafaxine extended release will offer physicians a new clinically proven option for treating depression."
Facts About Depression
Following are facts that substantiate the significant unmet patient need for efficacy in antidepressants and the enormous societal impact of depression.
Depression is the most common serious mental disorder worldwide * Depression affects approximately 121 million people worldwide and is the fourth leading cause of disability and premature death. * The World Health Organization projects that by the year 2020, depressive disorders will become the second-leading cause of disability worldwide. * Depression is the most prevalent mental health condition in the United States, affecting approximately 19 million American adults each year. * Studies indicate that depressive episodes occur twice as frequently in women as in men. Diagnostic criteria for Major Depressive Disorder include the following: * Depressed mood most of the day, nearly every day (subjectively reported or observed by others) * Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day (subjectively reported or observed by others) * Significant weight loss when not dieting or weight gain, or decrease or increase in appetite nearly every day Insomnia or hypersomnia nearly every day Psychomotor agitation or retardation nearly every day (as observable by others, not merely subjective feelings) Fatigue or loss of energy nearly every day Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day * Diminished ability to think or concentrate, or indecisiveness, nearly every day (subjectively reported or observed by others) * Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide More treatment options are needed * Researchers estimate that approximately 50 to 60 percent of patients suffering from depression respond to antidepressant therapy, leaving a large percentage of patients with unresolved depression. * Patients who experience one episode of depression have a 50 percent chance that it will recur within five years. About Antidepressants
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with MDD and other psychiatric disorders. Anyone considering the use of any antidepressant in a child or adolescent must balance the risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
About Wyeth
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade-buying patterns, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
WOW! Tons of SSRI & withdrawal side effect listed above...
December 24 2005, 4:07 PM
"...Diagnostic criteria for Major Depressive Disorder include the following: *
Depressed mood most of the day, nearly every day (subjectively reported or observed by others)
Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day (subjectively reported or observed by others)
Significant weight loss when not dieting or weight gain, or decrease or increase in appetite nearly every day
Insomnia or hypersomnia nearly every day
Psychomotor agitation or retardation nearly every day (as observable by others, not merely subjective feelings)
Fatigue or loss of energy nearly every day
Feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day
Diminished ability to think or concentrate, or indecisiveness, nearly every day (subjectively reported or observed by others)
Recurrent thoughts of death (not just fear of dying),
recurrent suicidal ideation without a specific plan,
or a suicide attempt or a specific plan for committing suicide ..."
How cleverly predictable of the 'Stakeholders' to call them 'depression'. Especially psychomotor agitation - isn't that another term for akathisia? If it is, then akathisia is a drug-induced condition.
