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Home > "P" Clinical Trials Conditions > Panic Disorder Study Panic Disorder Study
Panic Disorder Study
For Condition: Panic Disorder
Status: Not yet recruiting
Sponsor(s): Wyeth-Ayerst Research ,
Synopsis: The primary objective is to determine the efficacy, safety, and tolerability of venlafaxine extended release (ER) capsules in the treatment of outpatients with panic disorder (PD) in comparison to those of placebo.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - A male or female outpatient. - Must be at least 18 years of age. - Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1. - Have sufficient symptoms to require anxiolytic drug therapy. - Have a score of greater than or equal to 4 on the Clinical Global Impressions Scale (CGI) severity of illness item at screening and baseline. - Have a minimum of 8 full-symptom panic attacks during the 4 weeks before the screening visit. - Have a minimum of 4 full-symptom panic attacks during the 14 +/- 3 day placebo lead-in period between the screening and baseline (study day -1) visits. - Provide a signed and a dated written informed consent. - Have a Covi Anxiety Scale total score greater than the Raskin Depression Scale total score at screening and baseline. - Women of childbearing potential must have a negative serum pregnancy test at screening. The signed informed consent should reflect an awareness of the stipulations concerning the use of contraception. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Sexually active women participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy. Exclusion Criteria: - Treatment with venlafaxine (IR or ER) or paroxetine within 6 months of study day 1. - Known hypersensitivity to venlafaxine (IR or ER), related compounds, or paroxetine. - History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma [except basal cell epithelioma], uncontrolled hypertension). - Clinically important abnormality on screening physical examination, vital signs, electrocardiogram (ECG), laboratory tests or urine drug screen. - Pregnancy, lactation, plans to become pregnant during the study. - Oral contraceptives that have been taken for less than 3 months before study day 1 if not using another medically accepted form of birth control. - Use of any herbal products intended to treat anxiety, insomnia, or depression within 14 days of study day 1. - Myocardial infarction within 6 months of study day 1. - History or presence of a mental disorder due to a general medical condition. - History or presence of seizure disorder or a known history of more than one childhood febrile seizure. - History or presence of clinically important head trauma. - History or presence of any psychotic illness, bipolar affective disorder, or organic brain disease. - DSM-IV diagnosis of major depressive disorder, or generalized anxiety disorder (GAD) that is considered by the investigator as being primary, causing a higher degree of distress of impairment than PD. Patients with a diagnosis of secondary major depression or GAD may be eligible provided other exclusionary requirements are not met. - Any other clinically significant Axis I or Axis II disorder current or predominant within 6 months of study day 1 other than PD (with or without agoraphobia). - Screening or baseline Hamilton Depression Rating Scale (HAM-D) score greater than or equal to 18. - Screening or baseline HAM-D item 1 (depressed mood) score > 2. - History of drug or alcohol dependence or abuse as defined in DSM-IV within 1 year of study day 1. - Regular use of alcohol (more than 750 mL of beer/day or the equivalent). - Acutely suicidal to such a degree that precautions against suicide must be employed. - Screening urine drug screen positive for a drug of abuse. - A screening or baseline Raskin Depression Scale score greater than 3 on any single item or a Raskin total score >9. - Investigational drugs, investigational procedures, antipsychotics, fluoxetine, warfarin, sumatriptan, naratriptan, zolmitriptan or drugs with a similar mechanism of action indicated for the treatment of migraine within 30 days of study day 1. - Regular use (defined as 4 or more days a week) of benzodiazepines within 14 days of the screening visit. - Antidepressants (other than fluoxetine), monoamine oxidase inhibitors, nonbenzodiazepine anxiolytics within 14 days of study day 1. - Psychopharmacologic drugs (including anxiolytics, other antidepressants, lithium, stimulants, and sedative hypnotics other than zaleplon or zolpidem) within 14 days of study day 1. - Theophylline, cimetidine, propafenone, flecainide, encainide within 7 days of study day 1. - Nonpsychopharmacologic drugs with psychotropic effects taken within 7 days of study day 1, unless taken at a stable dose for at least 3 months before study day 1. - Cognitive behavioral therapy within 30 days of study day 1. - Introduction or change in intensity of formal psychotherapy (regularly scheduled sessions employing specific techniques) within 60 days of study day 1. - Electroconvulsive therapy (ECT) within 6 months of study day 1. - Known history or presence of raised intraocular pressure or narrow angle glaucoma.
Total Enrollment:
Location and Contact Information:
Hospital 2d de Noviembre ISSSTE
Mexico City, ,
Mexico
Francisco Valencia 52555-573-1200
Hospital de Psychiatrie
Station Catarina, ,
Mexico
Mario Tercero 52555-277-7370
Insurgentes Sur 3877
Mexico City, ,
Mexico
Ricardo Colin 52333-633-9383
Hospital Italiano
Capital Federal, ,
Argentina
Montaneses 2325
Capital Federal, ,
Argentina
Gustavo Petracca 54115-777-3200
Ministerio de Salud - Hospital San Pable de Coquimbo
Coquimbo, ,
Chile
Viola Fernandez 562-210-4080
Instituto Nacional de la Nutricion
Mexico City, ,
Mexico
Rafael Salin 525-511-9111
Centro de Salud Mental Communitarion
Queretaro, ,
Mexico
Luis Almeida 52555-200-5003
Grupo de Estudios Medicos y Familiares Carraci
Mexico City, ,
Mexico
Humberto Nicolini 52222-243-1445
Clinica  Privada  Neuropsiquiatrica  San  Augustin
Buenos Aires, ,
Argentina
Miquel Marquez 54114-866-2546
Instituto Costarricense de Investigaciones Clinicas
La Uruca, ,
Costa Rica
Juan Salas 563-257-3063
Clinica San Jorge
Buenos Aires, ,
Argentina
Guillermo Tortora 54114-240-9702
Hospital San Juan de Dios
Zapopan, ,
Mexico
Luis Rivero 52444-833-0444
Hospital Fray Bernadino Alvarez
Tlallpan, ,
Mexico
Fernando Corona 525-511-9111
Centro de Neuropsiquiatria
Aguascalientes, ,
Mexico
Isaac la Parra 52818-345-7260
Universidad de Chile - Departmento de Psiquiatria
Santiago de, ,
Chile
Larach Walters 562-632-0338
Instituto Mexicano de Investivacion Clinica
Mexico City, ,
Mexico
Hector Duenas 506-290-4242
Hospital Psiquiatrico San Francisco de Asis
Corrientes, ,
Argentina
Baltasar Mazzaro 5411378-346-6415
Instituto Frenopatico
Buenos Aires, ,
Argentina
Alberto Juan 5-411-4806
Hospital Angeles del Pedregal
Mexico City, ,
Mexico
Ricardo Secin 52333-633-0730
Instituto Mexicano de Investivacion Clinica
Mexico City, ,
Mexico
Juan Corral 506-290-4242
Centro Avanzado de Salud Animica
Monterrey, ,
Mexico
Jose Jesus Castillo 52555-652-2277
Plural PSI
Buenos Aires, ,
Argentina
Roger Montenegro 5611-774-4957
Hospital Espanol de Buenos Aires
Buenos Aires, ,
Argentina
Stella Diamanti 54114-931-3140
Centro de Psiquiatria Biologica
Mendoza, ,
Argentina
Julio Mingiorance 54261-425-7256
Clinica Privada Neuropsiquiatrica San Augustin
Buenos Aires, ,
Argentina
Alberto Bertoldi 54261-428-0320
Instituto Mexicano de Investivacion Clinica
Mexico City, ,
Mexico
Luis Martinez 506-290-4242
Hospital de la Salud Madre Perla
San Luis Potosi, ,
Mexico
Felipe Ortega 52818-347-3778
Instituto Jalicience de Salud Mental
Zoropan, ,
Mexico
Benjamin Becerra 52442-214-0639
Hospital Universitario de Nuevo Leon
Monterrey, ,
Mexico
Alfonso Ontiveros 52555-611-3028
Universidad de Chile - Clinica Psiquiatrica
Santiago, ,
Chile
Andres Lobens 562-263-2858
Hospital General de Agudos
Mercedes, ,
Argentina
Juan Distefanis 54232-440-0104
Additional Information:
Study ID Numbers: 0600B5-399-AC;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044772
Other Panic Disorder Studies:
1. Panic Disorder Study
2. Brain Chemical Receptor Effects in Patients with Panic Disorder and Post-Traumatic Stress Disorder
3. Randomized Study of Cognitive-Behavioral Therapy vs Imipramine and Their Combination for Panic Disorder
4. Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients with Anxiety
5. Treatment of Panic Disorder: Long Term Strategies
Related Studies:
Other Panic Disorder Clinical Trials
Other Clinical Trials
Other Queretaro Clinical Trials
Panic Disorder Study
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