The primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III study.

Condition	Treatment or Intervention	Phase
Panic Disorder	Drug: Venlafaxine ER	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• A male or female outpatient.
• Be at least 18 years of age and legal age of consent.
• 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 * 4 on the Clinical Global Impressions Scale (CGI) severity of illness item.
• 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 dated written informed consent.
• Have a Covi Anxiety Scale total score greater than the Raskin Depression Scale total score.
• 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) within 6 months of study day 1.
• Known hypersensitivity to venlafaxine (IR or ER) or related compounds.
• 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 1 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 or 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 * 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 24 ounces of beer/day or the equivalent).
• Acutely suicidal to such a degree that precautions against suicide must be employed.
• 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 screening or baseline Raskin total score >9.
• Investigational drugs, investigational procedures, antipsychotics, fluoxetine (Prozac®), sumatriptan (Imitrex®), naratriptan (Amerge®), zolmitriptan (Zomig®), or drugs with a similar mechanism of action indicated for the treatment of migraine within 30 days of study day 1.
• Regular use 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 (Sonata®) or zolpidem (Ambien®)) within 14 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.

Alabama
      Birmingham Research Group Inc., Birmingham,  Alabama,  35216,  United States
California
      Southwestern Research, Inc., Beverly Hills,  California,  90210,  United States
      Irvine Center for Clinical Research, Irvine,  California,  92618,  United States
      Southwestern Research, Inc., Beverly Hills,  California,  90210,  United States
Florida
      Miami Research Associates, Miami,  Florida,  33173,  United States
      Baumel-Eisner, Ft. Lauderdale,  Florida,  33321,  United States
      Research Site, St. Petersburg,  Florida,  33702,  United States
Georgia
      Research Site, Augusta,  Georgia,  30907,  United States
      Emory University, Atlanta,  Georgia,  30329 5102,  United States
      Atlanta Institute of Medicine and Research, Atlanta,  Georgia,  30076,  United States
Illinois
      Vine Street Clinic, Springfield,  Illinois,  62701 1098,  United States
      Neuropsychiatric Assoc. of Illinois, Chicago,  Illinois,  60061,  United States
Maryland
      Research Site, Rockville,  Maryland,  20852,  United States
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02144,  United States
New Jersey
      Comprehensive Clinical Research CNS, P.C., Clementon,  New Jersey,  8021,  United States
      Psychopharmacology Research Association of Princeton, Princeton,  New Jersey,  08540,  United States
New York
      Montefiore Medical Center, Bronx,  New York,  10467,  United States
      Social Psychiatry Research Institute, New York,  New York,  10021,  United States
      Eastside Comprehensive Medical Services, New York,  New York,  10021,  United States
      Depression and Anxiety Institute, Mount Kisco,  New York,  10549,  United States
Ohio
      Neurology Center of Ohio, Toledo,  Ohio,  43623,  United States
      Hartford Research Group, Cincinnati,  Ohio,  45229,  United States
Pennsylvania
      Allegheny Behavioral Health Science, Moon Township,  Pennsylvania,  15108,  United States
      Clinical Studies-Pittsburgh, Pittsburgh,  Pennsylvania,  15206,  United States
Virginia
      Charlottesville Medical Research, Charlottesville,  Virginia,  22902,  United States
Washington
      Northwest Clinical Research Center, Bellevue,  Washington,  98004,  United States
      Seattle Clinical Research Center, Seattle,  Washington,  98104,  United States
Wisconsin
      Northbrooke Research Center, Brown Deer,  Wisconsin,  53223,  United States
Canada
      Anxiety Disorder Clinic, Hamilton,  L8N 3Z5,  Canada
      Royal University Hospital, Saskatoon,  S7N OW8,  Canada
      Vancouver General Hospital, Vancouver,  V5Z 1M9,  Canada
Canada, British Columbia
      P.R. Latimer Medical Services, Inc., Kelowna,  British Columbia,  V1Y 2H4,  Canada
Canada, Quebec
      Q&T Recherche Inc., Sherbrooke,  Quebec,  J1H 4J6,  Canada
      Centre Hospitalier Universitaire de Quebec, Sainte-Foy,  Quebec,  GIV 4G2,  Canada

Study ID Numbers:  0600B5-353-US
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  June 5, 2002
ClinicalTrials.gov Identifier:  NCT00038896
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08