Annex to Chapter 6.15: Depressionin Young People and the Elderly
Priority Medicines for Europe and the World
"A Public Health Approach to Innovation"
Background Paper for Review
Annex to
Depressionin Young People and the Elderly
By Eduardo Sabaté
10 August 2004
Please send comments to:
Dr. Eduardo Sabaté:
Dr. Richard Laing:
Inventory of Clinical Trials already in the Market91
Trial / Condition / Study Design / Intervention / MechanismBIOLOGICAL
BASIC RESEARCH
Use of Complementary and Alternative Medicine Among Older Mexican Americans
/ Arthritis; Diabetes Mellitus; Fractures; Hypertension; Depression; Urinary Incontinence / 65+
Observational
1993-2000
Adolescence, Puberty, and Emotion Regulation
/ Mood Disorder; Neurobehavioral Manifestation; Healthy / 9-17 & 20-40
Observational
2001 / fMRI
The Psychobiology of Childhood Temperament
/ Mood Disorders; Anxiety Disorders; Adolescents / 9-16
Observational
2003-? / fMRI
Reward-Related Processes and Brain Function
/ Depression; Anxiety Disorders; Healthy / 9-17 + 20-40
Observational/Natural History / Development data
Reward-Related Processes and Brain Function
/ Depression; Anxiety Disorders; Healthy / 9-17 + 20-40
Observational/Natural History / Development data
Genetics of Fibromyalgia
/ Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome; Depression / 12+
Observational / Genetic Mapping
Brain Function in Mentally Ill Adolescents
/ Healthy; Posttraumatic Stress Disorder; Major Depressive Disorder / 9-17
Observational Study
2001-? / functional MRI
Epidemiology of Cardiovascular Risk Factors in Women (Healthy Women Study)
/ Cardiovascular Diseases; Heart Diseases; Depression; Carotid Artery Diseases; Menopausal Complaints; Menopause / Observational
1983-2007
Behavioral and Immunological Factors in Coronary Disease
/ Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression / Observational
2001-2006
Mechanisms Linking Depression to Cardiovascular Risk
/ Depression; Cardiovascular Diseases; Heart Diseases / Age?
Co-twins retrospective
2001-2005 / Relation CVD and depression
University of North Carolina AlumniHeart Study
/ Cardiovascular Diseases; Heart Diseases; Coronary Disease; Depression / Observational
1996-2005
Hostility, Depression, SocialEnvironment and CHD Risk
/ Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression / Observational
1997-2004
FMRI Study of Performance During a Probabilistic Reversal Learning Task in Depression / 18-50
Observational study
2004
Neurocardiac Control in Major Depression / Any
Observational
2004-? / combine H (2) (15) O positron emission tomography (PET) and analysis of heart rate variability (HRV)
Anxiety and Vagal Control ofthe Heart in Coronary Disease
/ Cardiovascular Diseases; Coronary Disease; Depression; Heart Diseases; Death, Sudden, Cardiac; Arrhythmia / Observational
1999-2004
Neuroanatomy of Emotion Regulation in Major Depressive Disorder
/ Major Depressive Disorder / 18-50
Observational
2003 / FMRI
Brain Regulation of Emotions inPeople with Depression and Anhedonia
/ Major Depressive Disorder / 18-50
Observational
2003 / FMRI
Effect of Acetylcholine on Thinking and Emotion in Individuals with Mood Disorders
/ Mood Disorders / 18-45
Observational
2003 / Scopolamine
fMRI
Framingham Offspring Study: Psychosocial Risk Factors
/ Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression; Atrial Fibrillation / Observational Study
2001-2003
Brain Imaging in Depression
/ Depression; Bipolar Disorder / 18-50
Observational
2002-2003 / Drug:[O-15] Water
Drug:[F-18] FP-TZTP
Dynamics of Leptin and Endocrine Function
/ Healthy; Involutional Depression / Observational
1996-2002 / Leptin as hypothalamus regulator and determinant of major depression
Effects of Hydrocortisone in Patients with Post-TraumaticStress Disorder
/ Post-Traumatic Stress Disorders; Healthy / 18-60
Observational
2002-? / PET Scan
Brain Chemical Receptor Effects in Patients with Panic Disorder and Post-Traumatic Stress Disorder
/ Panic Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder / Observational
2001 / Drug:O15 Water
Drug:FCWAY
Drug:flumazenil
PET Scan / 5-HT1A and BZD receptor function is abnormal in patients with PD, PTSD, and depression.
Stress hormone cortisol effects on 5-HT1A and BZD receptors
Do Hostility and Stress Predict Cardiovascular Mortality in MRFIT?
/ Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression / Observational
2001
Examination of Brain Serotonin Receptors in Patients with Mood Disorders
/ Mood Disorder / 18-60
Observational Study
2001-? / Drug:15 O-water
Drug:FCWAY
PET Scan / serotonin 1A (5-HT1A) receptor function is abnormal in patients with mood disorders
Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety)
/ Depressive Disorder; Mood Disorder; Psychomotor Agitation / 40-65
Observational
1998-2003
Neuroimaging of St. John's Wort-Induced Changes of Serotonin Metabolism in Normal Subjects
/ Healthy; Mood Disorder / Observational
1999-2002 / Drug:Hypericum (LI-160)
Consequences of Conjugal Bereavement in Adults
/ Bereavement; Depressive Disorder; Immunologic Disease; Mental Disorder; Sleep Disorder / ?
1997-2002
Effects of Sex Hormones on Circadian Rhythm in Men and Women
/ Bipolar Disorder; Circadian Rhythm; Depressive Disorder / 18-45
Observational
1999-2001
Study of the Hypothalmic-Pituitary-Adrenal (HPA) Axis and its Rolein Major Depression
/ Fatigue Syndrome, Chronic; Healthy; Mood Disorders / Any
Observational
1995-2000
Glucocorticoid Effects on Cellular Cytokine Release
/ Depressive Disorder; Fatigue Syndrome, Chronic; Fibromyalgia; Healthy; Inflammation / Any
Observational
1994-2000
Use of Repetitive Transcranial Magnetic Stimulation (rTMS) in Chronic Posttraumatic Stress Disorder (PTSD) / 18-70
Observational
1997-? / Repetitive Transcranial Magnetic Stimulation (rTMS)
Impact of Sleep Disordered Breathing in Older Adults
/ Cardiovascular Diseases; Hypertension; Depression; Sleep Apnea Syndromes; Lung Diseases / Males Age?
Observational
1994-1998
Prediction of Quality of Life in Cardiovascular Disease
/ Cardiovascular Diseases; Cerebrovascular Accident; Hypertension; Depression; Heart Diseases / Observational
1992-1995
The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders
/ Depressive Disorder; Healthy; Mental Disorders; Mood Disorders / 18-65
Observational
1988-2000
Perimenopause-Related Mood and Behavioral Disorders
/ Depressive Disorder; Healthy / 40-60
Observational
1988
Study of Menstrually-Regulated Mood and Behavioral Disorder
/ Mental Disorder; Mood Disorder / 18-50
Observational
1981
Clinical trials of two non-drug treatments for chronic depression
/ Mood Disorders; Depressive Disorders; Depression; Chronic depression; Nonseasonal depression / 18-65
Randomized,Single Blind,Dose Comparison,Parallel Assignment,Efficacy Study / Device:Bright light box
Device:Negative ion generator / Circadian clock
The Effects of Hormone Withdrawal on Mood Symptoms in Women with Perimenopausal Depression
/ Perimenopause; Depression / HRT Withdrawal
Serotonin Function During Depression
/ Depression, Involutional; Healthy / 18-60
Experimental Clinical Physiology
Genetic Mapping / Drug:[O-15] Water
Drug:[F-18] FDG
PET Scan / tryptophan depletion & central serotonergic systems
MRI Study of Brain Activity and Risk for Depression in Adolescents
/ Involutional Depression; Anxiety Disorders / 10-17
Observational/Natural History
Brain functioning w/ MRI / Adolescent under risk (depressed parents)
Heart Disease Risk Factors in Major Depression
/ Adrenal Gland Hyperfunction; Cardiovascular Disease; Involutional Depression / 18-65
Observational/Natural History / IHD Factors
Genetics of Recurrent Early-Onset Depression
/ Depression / 18-70
Observational
Genetic mapping / Genetic Risk Factors
Use of Bone Biopsy to Better Understand the Causes of Decreased Bone Mineral Density in Depression
/ Bone Diseases, Metabolic; Depression, Involutional; Osteoporosis / Any with OP
Observational / Bone Biopsy for Histomorphometry and Analysis of Bone Marrow / Unknown
Bone Mineral Density in Women with Major Depression
/ Healthy; Involutional Depression; Osteoporosis / Observational
Diagnostics
Any with OP / non-radioactive calcium isotopes + dual X-ray absorptiometry (DEXA) scan / Unknown
Women's Use of Alternative Medicine: A Multiethnic Study
/ Uterine Fibroids; Osteoporosis; Urinary Tract Infection; High Blood Pressure; Heart Disease; Arthritis; Depression; Headaches / 18+ Females
Observational
2001-2001
PSICOLOGICAL
BASIC RESEARCH
Validation and Exploration of Sleep and Mood Predictors
/ Sleep Apnea Syndromes; Depression; Lung Diseases; Sleep / Observational
1995-1999
Major depression and inflammatory risk markers for coronary heart disease
/ Depression / 18-55
Observational
Mediators of Social Support in Coronary Disease
/ Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Depression / Observational Study
1992-1998
Interactions of Depressed Mothers with Their Infants
/ Healthy; Depression / Child development
Psychosocial Correlates and Coping Strategies Associated with Long-Term Survival of HIV-Infected Children
/ Acquired Immunodeficiency Syndrome; Depressive Disorder; HIV Infections / 8-18
Observational
Study of the Psychological Development of Children of Parents with and without Affective Disorders
/ Bipolar Disorder; Involutional Depression; Mood Disorder / Observational/Natural History / Adolescent under risk (depressed parents)
Platelet Function in Patients Treated with SSRI and non-SSRI Antidepressants
/ Depression / 18+
Naturalistic / SSRI decrease platelet serotonin
TECHNOLOGY
CLINICAL RESEARCH
Treatment forAdolescents With Depression Study (TADS)
/ Major Depressive Disorder; Depression / 12-17yo
RCT,Placebo, C/E
Phase III / Drug:Fluoxetine
Behavior:Psychotherapy / SSRI
Treatment Of ResistantDepression In Adolescents (TORDIA)
/ Major Depressive Disorder; Dysthymic Disorder; Depression / 12-18 yo
RCT, Efficacy Study
Phase III / Drug:fluoxetine (Prozac)
Drug:venlafaxine (Effexor XR)
Procedure:Cognitive Behavioral Therapy (CBT)
Drug:citalopram (Celexa) / Optimizing Protocol
SSRI vs Non-SSRI
Clinical Trial of Memantine for Major Depression
/ Depression / 18-80yo
Safety & Efficacy
Phase III / Memantine HCL / glutamatergic system
Riluzole to Treat Major Depression
/ Depression / 18-70yo
Safety/Efficacy
Phase II / Riluzole / antiglutamatergic and neuroprotective properties
Examination of a Soy-Based Supplement for Major Depression
/ Depression / 18+
RCT Safety/efficacy / soy isoflavone genistin / phytoestrogen and protein tyrosine kinase inhibiting properties
Antidepressant Treatment of AIDS Related Depression.
/ Depression / 18-65yo
RCT
Phase II / Imipramine hydrochloride
Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
/ Depression / 18-75
RCT
Phase IV / Drug:citalopram
Drug:BuproprionSR
Drug:buspirone
Drug:Lithium
Drug:mirtazapine
Drug:nortriptyline
Drug:sertraline
Drug:tranylcypromine
Drug:VenlafaxineXR
Behavior:Cognitive Therapy
Drug:T3 (Triiodothyronine) / Protocol Optimization
Preventing the Return of Depression in Elderly Patients
/ Depression / 60-80
RCT
Phase ? / Nortriptyline / Chronic therapy for unsustainable remissions
Olanzapine Versus Active Comparator in the Treatment of Depressionin Patients with Schizophrenia
/ Depression; Schizophrenia; Schizoaffective Disorder / 18-60
RCT
Phase IV / Olanzapine and investigational agent / N/a
Antidepressant Treatment of Melancholia in Late Life
/ Depression; Melancholia / 60+
RCT
Efficacy & Safety / Drug:Sertraline
Drug:Nortriptyline / SSRI vs TCAs
Clinical Trial of Estrogen for Postpartum Depression
/ Postpartum Depression / 20-45
RCT
Safety & Efficacy
Phase II / 17 beta-estradiol / declining estradiol secretion
Depression in Alzheimer's Disease (DIADS-2)
/ Alzheimer's Disease; Depression / All Alzheimer patients
RCT
Phase III / Drug:sertraline (Zoloft)
Drug:Placebo
Biological Aspects of Depression and Antidepressant Drugs
/ Depression / 21-69
RCT / Drug:paroxatine
Drug:Desipramine
Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
/ Smoking; Depression / 18-65
RCT
Phase II / Drug:Fluoxetine
Behavior:Behavioral group smoking cessation treatment / Unknown
Depression and Health Outcomesin Refractory Epilepsy
/ Depression; Epilepsy / 21-75
RCT
Compliance
Phase III / Drug:sertraline
Behavior:cognitive behavior therapy / Comparison Sertaline vs CHT
Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients with Major Depression and Pain
/ Depression; Pain / 18+
RCT
Safety/Efficacy Study / Duloxetine Hydrochloride / na
Treatment of Depression in Youth with Bipolar Disorders
/ Bipolar Disorder; Depression / 8-18
RCT
Phase III / Fluoxetine / Na
Treatment of Depression in Parkinson's Disease Trial
/ Parkinson Disease; Depression / 35-80
RCT Safety/Efficacy Study
Phase II / Drug:nortriptyline
Drug:paroxetine
Magnetic Stimulation for Parkinson Disease
/ Parkinson's Disease; Depression / 40-75
RCT / Procedure:Prefrontal transcranial magnetic brain stimulation & ECT / Neurostimulation improve mood and psychomotor
Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
/ Depression; Mood Disorder; Anxiety Disorder; Healthy / 9-17
Observational / Fluoxetine / Improve attention and emotional memory
Treatment of Depression with Massage in HIV
/ Acquired Immunodeficiency Syndrome; HIV Infections; Depression / 16+
RCT Efficacy
Phase II / Procedure:Massage Therapy / Plasma cortisol increases?
Treatment Effects on PlateletCalcium in Hypertensive and Depressed Patients
/ Depression; Hypertension / 25-65
RCT - Pharmacodynamics / Drug:paroxetine
Behavior:ongoing psychological screening / Platelets of hypertensive patients with depressive symptomatology are hyper-responsive to serotonin
Combination Chemotherapy Plus Fluoxetinein Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
/ Anxiety Disorder; Depression; Fatigue; Non-small cell lung cancer / Any with SCC
RCT / Drug:cisplatin
Drug:fluoxetine
Drug:gemcitabine
Procedure:chemotherapy
Procedure:psychosocial assessment/care
Procedure:supportive care/therapy / Improving treatment protocol
Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
/ adult brain tumor; brain metastases; cognitive and functional effects; Depression; Fatigue; Quality of Life / 18+
RCT / Drug:methylphenidate
Complications of therapy assess/mgt
Fatigue assess/mgt
Psychosocial assess/mgt
Quality-of-life assessment
Radiation therapy
Supportive care/therapy / Improving QoL
PUFA Augmentation in Treatment of Major Depression
/ Major depression / 18-65
RCT Efficacy
Phase III / Drug:Polyunsaturated Fatty Acids (PUFA)
Drug:Citalopram / PUFA enhance Antidepressant therapy
Treatment of Major Depression with St. John's Wort (Hypericum)
/ Major Depression / 18+
RCT efficacy and safety
Comparative study of a natural medicine / Drug:Sertraline
Drug:Hypericum perforatum (St. John's wort)
Treatment Resistant Depression Study
/ Depression; Major Depressive Disorder / 18-85
RCT Phase III
2002-open / risperidone
Medication Treatment for Psychotic Depression
/ Depression; Major Depressive Disorder / 18+
RCT Safety & Efficacy
2003-2007 / Drug:Olanzapine
Drug:Sertraline
Drug:Lithium / First trial MD with delusions funded by NIMH
Raloxifene and Rimostil for Perimenopause-Related Depression
/ Climacteric Depression / Any
RCT Phase IV
2002-? / Drug:Evista, Rimostil, Alora / Selective estrogen receptor modulators (SERMS)
Transcranial magnetic stimulation in depression
/ Depression / 18+
RCT Phase II
1999-2001 / Device:repetitive transcranial magnetic stimulation
Multiphase Efficacy Study of venlafaxine ER to Treat Recurrent Depression
/ Depression / 18+
RCT
Phase IV
2002-? / Drug:Venlafaxine ER
Drug Therapy to Treat Minor Depression
/ Depression / 18-85
RCT
2003-? / Drug:Citalopram
Drug:St. John's Wort
Preventing the Recurrence of Depression with Drugs and Psychotherapy
/ Depression / 18+
RCT Efficacy
Phase IV
2002-? / Behavior:Cognitive Therapy
Drug:Antidepressant medications / CT to avoid recurrence
Duloxetine vs. active comparator for the treatment of depression
/ Depression / 18+
RCT Efficacy
Phase IV / Drug:Duloxetine Hydrochloride
Drug: Other
Electroconvulsive Therapy (ECT) Versus Drug Therapy for the Treatment of Depression
/ Depression / 18-85
RCT Efficacy & Safety / Drug:Lithium
Drug:Nortriptyline
Procedure:Continuation Electroconvulsive Therapy / For avoiding relapse after ECT
Compares Drugs vs C-ECT
Comparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major Depression
/ Depression / 18+
RCT
2002-? / Procedure:Electroconvulsive Therapy (three application procedures) / Improving technique
Duloxetine vs. active comparator in the treatment of patients with depression
/ Depression / 18+
RCT
Phase IV
2004? / Drug:Duloxetine Hydrochloride
An Investigational Drug Compared to a Marketed Drug and Placebo in the Treatment of Patients with Depression
/ Depression / 18+
RCT
Phase III
2004? / Drug:Investigational antidepressant drug
Participant Features Affecting Depression Treatment
/ Depression / 18-66
RCT Efficacy
2003-2007 / Drug:Escitalopram
Behavior:Interpersonal Psychotherapy / Comparative
Medication Treatment for Depression in Nursing Home Residents
/ Depression / 65+
RCT Safety/Efficacy Study
Phase IV
2003-2008 / Drug:Antidepressants
Acupuncture in the Treatment of Depression
/ Depressive Disorders; Depression / 18-60
RCT
Phase III
1997-2002 / Procedure:Acupuncture
Magnetic Stimulation Therapy for Treating Vascular Depression
/ Depressive Disorder; Depression / 51-89
RCT Efficacy/Safety
Phase III
2001-? / Procedure:Repetitive Transcranial Magnetic Stimulation
Drug:Citalopram
Treatment of Vascular Depression
/ Depressive Disorder; Depression / 60+
RCT efficacy and Pharmacocinetic / Drug:Sertraline (Zoloft)
Procedure:MRI Scan
Procedure:Cognitive Testing
Procedure:EKG
Ethnic Variations in Antidepressant Response
/ Depression; Depressive Disorder / 18-70
RCT Efficacy
Phase IV
2002 / Drug:Citalopram
Research Evaluating the Value of Augmenting Medication with Psychotherapy (REVAMP)
/ Depression; Depressive Disorder / 18-75
RCT Efficacy
2003-2006 / Behavior:Supportive Therapy
Behavior:Cognitive Behavioral Analysis System of Psychotherapy
Drug:Sertraline
Drug:Escitalopram
Drug:Bupropion SR or XL
Drug:Venlafaxine XR
Drug:Mirtazapine / ST in drug failure cases
Improving Hispanic Retention in Antidepressant Therapy
/ Depression; Depressive Disorder / Hispanics 18-65
Non-Ramdomized
2002-2004 / Drug:Sertraline
Drug:Venlafaxine Extended Release / Treatment retention
Electroacupuncture for Major Depression
/ Depression; Depressive Disorder / 18-80
RCT Phase II / Procedure:electroacupuncture
Sertraline and Cognitive Therapy in Depressed Alcoholics
/ Alcoholism; Depression / 18-65
RCT Efficacy
Phase II
?-2002 / Drug:sertraline (Zoloft)
Behavior:cognitive behavior therapy
Sertraline for Alcohol Dependence and Depression
/ Alcoholism; Depression / 21-65
RCT Phase IV
?-2004 / Drug:naltrexone (Revia)
Drug:sertraline (Zoloft)
Drug Treatment for DepressedAlcoholics (naltrexone/fluoxetine)
/ Alcoholism; Depression / 18-65
RCT Phase IV
?-2005 / Drug:naltrexone (Revia)
Drug:fluoxetine (Prozac)
Treating Alcohol Use In Older Adults With Depression
/ Alcoholism; Depression / 55+
RCT Phase IV
1999-2002 / Drug:NALTREXONE
Relapse Prevention for Bipolar Type-II Disorder
/ Bipolar Disorder; Depression / 18+
RCT Phase IV / Drug:Fluoxetine
Drug:Lithium
Antidepressant Medication Treatment for Depression in Individuals with Congestive Heart Failure
/ Heart Failure, Congestive; Depression / 45+
RCT Efficacy
Phase III
? / Drug:Sertraline
The Depression in Alzheimer's Disease Study (DIADS)
/ Alzheimer Disease; Depression / Any
RCT Phase IV
? / Drug:Sertraline [Zoloft]
Preventing Post-Stroke Depression
/ Depression; Cerebrovascular Accident / 31-89
RCT Phase III
2002-? / Drug:Nortriptyline
Behavior:Problem Solving Therapy
Drug:Escitalopram
Optimizing Electroconvulsive Therapy for Depression
/ Depression; Depressive Disorder; Bipolar Disorder / 18+
RCT Phase IV
2001-2006 / Procedure:Electroconvulsive therapy
Drug:Nortriptyline
Drug:Venlafaxine
Drug:Lithium
SAM-e for the Treatment of Depression in Patients with Parkinson's Disease
/ Parkinson's Disease; Depression / 30-80
RCT
2003-2006 / Drug:s-adenosyl-methionine
Drug:escitalopram
Sertraline Compared With Hypericum Perforatum (St. John's Wort) in Treating Mild to Moderate Depression in Patients With Cancer
/ Depression; unspecified adult solid tumor, protocol specific / 18+
RCT
? / Drug:Hypericum perforatum
Drug:sertraline
Procedure:biologically based therapies
Procedure:cancer prevention intervention
Procedure:complementary and alternative therapy
Procedure:herbal medicine / botanical therapy
Procedure:nutritional supplementation
Procedure:psychosocial assessment/care
Procedure:supportive care/therapy
Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment