anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: Participants were administered one 10 mg asenapine tablet, sublingually BID for 21 days
Eligibility criteria:
Inclusion Criteria:

Each participant must be at least 18 years of age
Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
Each participant must have discontinued the use of all prohibited psychotropic medications

Exclusion Criteria:

A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
Intervention: Hydroxychloroquine
Trial phase: Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Hydroxychloroquine 400 mg po daily for up to one year.

Hydroxychloroquine: 400mg by mouth daily x 1 year
Eligibility criteria:
Inclusion Criteria:

Flow cytometry confirmed B-CLL
No prior chemotherapy or immunotherapy
Performance status 0-2
Age > 18 years old
If childbearing age, woman you must be willing to use birth control for length of hydroxychloroquine use
Must have capacity to consent for study and sign consent form
Asymptomatic CLL not requiring treatment at time of study entry

Exclusion Criteria:

Pregnancy
Significant optic nerve pathology as documented by an opthalmologic exam
Hypersensitivity to 4-aminoquinoline compound
Patients taking cardiac glycosides and cyclosporine
Intervention: Cycloserine
Trial phase: Phase 2
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants received DCS prior to cocaine cue exposure sessions.
Eligibility criteria:
Inclusion Criteria:

Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
Subjects must meet DSM-IV criteria for current cocaine dependence. Subjects may meet criteria for abuse, but not dependence on any other substance within the past 60 days with the exception of nicotine. Because of the high comorbidity of cocaine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the testing session will be controlled. Alcohol has also been known to affect HPA function, however to enhance recruitment efforts individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification.
Use of one of the following methods of birth control by female subjects: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
Subjects must live within a 50-mile radius of our research program and have reliable transportation.
Subjects must consent to remain abstinent from all drugs of abuse (except nicotine or alcohol) for 24 hours immediately prior to the GCRC admission.
Subjects must consent to random assignment to the DCS vs. placebo conditions.

Exclusion Criteria:

Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect heart rate or skin conductance measurement.
Individuals with creatinine clearance of 1.2 or greater as DCS is renally excreted.
Subjects with a history of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder as these may impact cue reactivity.
Subjects who are unwilling or unable to maintain abstinent from alcohol and other drugs of abuse (except nicotine) for 24 hours days prior to the cue procedure.
Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or cocaine as appropriate) within the past 60 days.
Subjects currently taking B-blockers, anti-arrythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
Known or suspected hypersensitivity to DCS.
Individuals taking medications that could adversely interact with study medications, including, but not limited to ethionamide, isoniazid, or amino acid supplements.
Subjects with a history of epilepsy or seizure disorder.
Subjects with significant liver impairment as DCS may increase serum transaminases.
Intervention: Methylene Blue
Trial phase: Phase 2
ATC code: V03AB17 | V04CG05
SMILES: CN(C)c1ccc2nc3ccc(=[N+](C)C)cc-3sc2c1.[Cl-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 62
Group description: One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes
Eligibility criteria:
Inclusion Criteria:

Stage 0,I, II breast cancer
Clinical node status N0, N1
No know allergy to iodine, lymphazurin or methylene blue dyes

Exclusion Criteria:

Patient cannot be pregnant or nursing
Prisoners will not be eligible
Women under the age of 18 will not be eligible
Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes
Intervention: Glycerin
Trial phase: Not Applicable
ATC code: A06AG04 | A06AX01
SMILES: OCC(O)CO
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: glycerol infusion into trained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Eligibility criteria:
Inclusion Criteria:

Regardless of training status, age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type 29 and we would like to limit the confounding effects of age.
We will define the lean group by a BMI of < 25 kg/m2. Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
The untrained subjects must not be engaged in a regular exercise program (< 30 minutes regular exercise over 1 week).
The trained subjects should be participating in regular running exercise (> 45 min/day, ≥ 5 days/week) and preferably be currently or recently participating in competitions (within 2 years).

Exclusion Criteria:

Regardless of training status, subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills or diuretics.
The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire. We will also administer a PAR-Q questionnaire (attached) to establish whether the subject will be safe for exercise testing. - The female subjects must not be pregnant. A pregnancy test will be performed prior to all study visits.
If screening TG are > 300 (based on 1st visit results) or fasting glucose > 100 (based on 1st visit results), the subjects will be excluded.
If the subject is allergic to eggs (used in lipid emulsions), soybeans(used in lipid emulsions), or lipid emulsions the subject will be excluded from the study.
Subjects taking anti-platelet agents (if anti-platelet agent cannot be held for seven days) and subjects taking anticoagulation therapy will be excluded.
Subjects with clinically significant medical issues or a history of hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5), pulmonary, or cardiac abnormalities (including abnormal EKG) will also be excluded.
Intervention: Glycerin
Trial phase: Not Applicable
ATC code: A06AG04 | A06AX01
SMILES: OCC(O)CO
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: glycerol infusion into untrained subjects

glycerol: glycerol infusion (2.25 g/100ml) will be administered at 1.5 ml/min,
Eligibility criteria:
Inclusion Criteria:

Regardless of training status, age range will be from age 18 to 45. We will be limiting the upper age range because increased age is associated with sarcopenia and alteration of fiber type 29 and we would like to limit the confounding effects of age.
We will define the lean group by a BMI of < 25 kg/m2. Weight must be stable [+/- 5 pounds] for at least the three months prior to the study for all participants.
The untrained subjects must not be engaged in a regular exercise program (< 30 minutes regular exercise over 1 week).
The trained subjects should be participating in regular running exercise (> 45 min/day, ≥ 5 days/week) and preferably be currently or recently participating in competitions (within 2 years).

Exclusion Criteria:

Regardless of training status, subjects must not be on medications that may affect lipid levels, specifically lipid lowering agents, birth control pills or diuretics.
The subjects should not be on a high fat diet (> 45% fat) as measured by a screening questionnaire. We will also administer a PAR-Q questionnaire (attached) to establish whether the subject will be safe for exercise testing. - The female subjects must not be pregnant. A pregnancy test will be performed prior to all study visits.
If screening TG are > 300 (based on 1st visit results) or fasting glucose > 100 (based on 1st visit results), the subjects will be excluded.
If the subject is allergic to eggs (used in lipid emulsions), soybeans(used in lipid emulsions), or lipid emulsions the subject will be excluded from the study.
Subjects taking anti-platelet agents (if anti-platelet agent cannot be held for seven days) and subjects taking anticoagulation therapy will be excluded.
Subjects with clinically significant medical issues or a history of hematologic (platelets < 100), hepatic (LFTs > 2X nl), renal (Cr > 1.5), pulmonary, or cardiac abnormalities (including abnormal EKG) will also be excluded.
Intervention: Quetiapine Fumarate
Trial phase: Phase 3
SMILES: O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 228
Group description: Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)
Eligibility criteria:
Inclusion Criteria:

Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode
Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months
MADRS-Score ≥ 25 at enrolment and randomisation

Exclusion Criteria:

Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation
Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months
Intervention: Nelfinavir
Trial phase: Phase 2
ATC code: J05AE04
SMILES: [H][C@@]12CCCC[C@]1([H])CN(C[C@@H](O)[C@H](CSc1ccccc1)NC(=O)c1cccc(O)c1C)[C@H](C(=O)NC(C)(C)C)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Nelfinavir: 1250 mg twice daily starting for approximately 6.5 weeks.
Eligibility criteria:
Inclusion Criteria:

Histological diagnosis of non-small cell lung cancer that is Stage III (T1-3, pN2, M0) NSCLC in whom neoadjuvant therapy is recommended.
Must have had a mediastinoscopy to determine nodal status and potential resectability
Must have enough tissue from the biopsy for tissue marker determination for correlative studies
Negative metastatic work up (FDG PET/CT, brain CT or MRI)
No prior thoracic radiotherapy will be permitted
Age 18 years or greater
ECOG performance status 0-1 (Karnofsky at least 70%)
Normal organ and marrow function
No known HIV infection
Not pregnant
Ability to understand and the willingness to sign an informed consent document

Exclusion Criteria:

Patients requiring a pneumonectomy
Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study, or who have not recovered from adverse events due to agents administered earlier.
Prior thoracic radiation
Treatment with any other investigational agents.
Known metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to NFV
Patients receiving drugs contraindicated with NFV will be excluded.
Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study compliance.
Pregnant or lactating women
HIV-positive patients on combination antiretroviral therapy
Intervention: INSULIN DETEMIR
Trial phase: Phase 4
ATC code: A10AE05
SMILES: CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
Body Mass Index (BMI) between 27.5-40 kg/m^2

Exclusion Criteria:

Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
Previous or planned surgical treatment of obesity
Total daily insulin dose higher or equal 2 IU/kg
Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
Receipt of any investigational drug within 1 month prior to this trial
Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: One drop self administered in the study eye(s) once daily at night for 12 weeks
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
Best corrected visual acuity of -0.6 logMAR or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Treatment with BAK preserved artificial tears within 30 days of Visit 1.
Known or suspected Sjogren's disease.
Uncontrolled IOP.
History or evidence of infectious or inflammatory ocular conditions.
Progressive retinal or optic nerve disease.
Ocular laser surgery within 3 months of Visit 1.
Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
Current use of punctal plugs or punctal cautery.
Use of systemic medications that has not been stable for 30 days prior to Visit 1.
Use of contact lens within 30 days of Visit 1.
Other protocol-defined exclusion criteria may apply.
Intervention: Laninamivir octanoate
Trial phase: Phase 3
SMILES: CCCCCCCC(=O)OCC(O)C(OC)C1OC(C(=O)O)=CC(N=C(N)N)C1NC(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 337
Group description: CS-8958 powder to be inhaled - high-dose arm
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of influenza
Axillary temperature of > or = to 37.5 degrees C

Exclusion Criteria:

Infection by bacteria species and/or virus other than influenza virus
Chronic respiratory disease
Renal dysfunction
Intervention: Laninamivir octanoate
Trial phase: Phase 3
SMILES: CCCCCCCC(=O)OCC(O)C(OC)C1OC(C(=O)O)=CC(N=C(N)N)C1NC(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 326
Group description: CS-8958 powder to be inhaled - low-dose arm
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of influenza
Axillary temperature of > or = to 37.5 degrees C

Exclusion Criteria:

Infection by bacteria species and/or virus other than influenza virus
Chronic respiratory disease
Renal dysfunction
Intervention: Relistor
Trial phase: Phase 3
ATC code: A06AH01
SMILES: C[N+]1(CC2CC2)CCC23c4c5ccc(O)c4OC2C(=O)CCC3(O)C1C5.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1034
Group description: Participants received MOA-728 12 mg SC QD for 48 weeks. Dosing could be adjusted to PRN basis with a minimum 1 dose per week and maximum 1 dose per day.
Eligibility criteria:
Inclusion Criteria:

Men and women 18 years or older.
A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
A history of constipation due to opioid use during 1 month before the screening visit.

Exclusion Criteria:

A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
A history of chronic constipation before initiation of opioid therapy.
Intervention: Bazedoxifene
Trial phase: Phase 3
ATC code: G03CC07 | G03XC02
SMILES: Cc1c(-c2ccc(O)cc2)n(Cc2ccc(OCCN3CCCCCC3)cc2)c2ccc(O)cc12
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 230
Group description: Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
Eligibility criteria:
Inclusion Criteria:

Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL
Intact Uterus

Exclusion Criteria:

Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: At the beginning of spinal surgery, patients will receive 1 hour dexmedetomidine intravenous bolus of 0.7 mcg/kg, followed by infusion of dexmedetomidine at a rate of 0.5 mcg/kg/hour for 2 hours, followed by an infusion of dexmedetomidine at a rate of 0.2 mcg/kg/hour for the duration of the procedure and for 4 hours after the procedure.

Dexmedetomidine: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) Classification I - III
Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels

Exclusion Criteria:

Allergy to dexmedetomidine
Cardiac disease with reduced ejection fraction < 30%
History of cirrhosis, active hepatitis or attenuated hepatic function
Chronic use of steroids, COX-2 inhibitors, alpha-2 agonists, or statins
Current anticoagulant therapy
Patients requiring motor evoked potential (MEP) monitoring
Positive pregnancy test
Intervention: Quetiapine Fumarate
Trial phase: Phase 3
SMILES: O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 92
Group description: Quetiapine XR 150 to 300mg once a day
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.
The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
Patients must be able to swallow the study medication tablets.

Exclusion Criteria:

The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.
Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
Patients who in your doctors judgement pose a current suicidal or homicidal risk.