anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fulvestrant
Trial phase: Phase 2
ATC code: L02BA03
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])c3ccc(O)cc3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
Eligibility criteria:
Inclusion Criteria:

Must give signed written informed consent
Must be of age 18 years or older
Histologically confirmed adenocarcinoma of the prostate
Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy
Must have had rise in PSA despite anti-androgen withdrawal
Must exhibit two consecutive rises in PSA after the last hormonal manipulation
Minimum PSA > 5mg/dL
KPS > 80%
Up to one prior chemotherapy treatments allowed
Life expectancy of greater than 6 months

Exclusion Criteria:

Concomitant hormonal therapy other than an LHRH
Noncompliance
Platelets less than 100 x 10e9 /L
International normalization ratio (INR) greater than 1.6
Total bilirubin greater than 1.5 x ULRR
ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases
History of bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency)
History of long-term anticoagulant therapy (other than antiplatelet therapy)
History of hypersensitivity to active or inactive excipients of fulvestrant (ie, castor oil or Mannitol)
Intervention: Citalopram
Trial phase: Phase 2
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria are:

Fulfilling Rome II IBS definition;
Age ≥18 yrs and able to give informed consent;
Normal sigmoidoscopy, colonoscopy or barium enema within 5 years, normal complete blood count and thyroid studies, and negative stool ova and parasite exam for patients with diarrhea.

Exclusion Criteria:

Exclusion criteria are:

Current psychiatric diagnosis or active treatment with antidepressants;
Pregnancy;
Major systemic illness, or illness that could explain IBS-like symptoms;
Active IBS therapy other than fiber or loperamide.
Intervention: Famciclovir
Trial phase: Phase 4
ATC code: J05AB09 | S01AD07
SMILES: CC(=O)OCC(CCn1cnc2cnc(N)nc21)COC(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 206
Group description: Famciclovir 1000 mg; twice a day for one day for treatment.
Eligibility criteria:
Inclusion Criteria:

Black men or women 18 years or older
History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy
Documented herpes simplex virus type 2 (HSV-2) seropositivity
Willingness to discontinue suppressive therapy during study, if applicable
Willingness and ability to comply with the study protocol

Exclusion Criteria:

Pregnant or breastfeeding women
Women of childbearing potential not using accepted methods of contraception
Hypersensitivity to famciclovir or drugs with similar chemical structures
Renal dysfunction
Known or suspected to have decompensated liver disease
Known to have gastrointestinal malabsorption
Known to be immunocompromised
Known to be hypersensitive to ingredients in study medication
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Donepezil Hydrochloride
Trial phase: Phase 4
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants received donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Men and women, aged 50 and older with mild Alzheimer's disease (MMSE scores of 20 to 30 are allowed).
Diagnostic evidence of Alzheimer's disease.
Previous use of cholinesterase inhibitors (other than Aricept) and memantine allowed.

Exclusion Criteria:

Prior use of Aricept, pacemakers and insulin dependent diabetes are not allowed.
Intervention: Morphine
Trial phase: Phase 3
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 170
Group description: Morphine IR 20mg 4-6 hourly
Eligibility criteria:
Inclusion Criteria:

Female between 18 and 80 years of age;
Scheduled to undergo an abdominal hysterectomy with or without bilateral salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or endometrial hyperplasia;
Anesthesiological and surgical procedures performed according to protocol;
Moderate or severe baseline pain following hysterectomy on a Verbal Rating Scale (VRS) within 6 hours following the last possible application of morphine subcutaneous;
Pain following hysterectomy of at least 4 on an 11-point Numeric Rating Scale (NRS) within 6 hours following the last possible application of morphine subcutaneous;
American Society of Anesthesiologists (ASA) classification I-III.

Exclusion Criteria:

Vaginal hysterectomy;
Ongoing or known history of painful endometriosis;
Known or suspected chronic pelvic pain syndrome;
Previous abdominal or pelvic open surgery;
History of seizure disorder or epilepsy;
History of alcohol or drug abuse;
Evidence of active infections that may spread to other areas of the body;
severely impaired renal function, moderately or severely impaired hepatic function,
Allergy or hypersensitivity to oxycodone, morphine, fentanyl hydromorphone, heparin, or any compound planned to be used during the anesthesia;
Serious complication during surgery and up to randomization;
Pre-operative use within 12hours prior to surgery or peri-operative use of non-steroidal anti-inflammatory drugs (NSAIDs);
Treated regularly with opioid analgesic or non-steroidal anti-inflammatory drugs (NSAIDs) within 30 days prior to screening;
Intervention: Ketorolac Tromethamine
Trial phase: Not Applicable
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Acular LS - 1 drop in treated eye, 4 times a day, for 4 days

Acular LS: Details covered in arm description
Eligibility criteria:
Inclusion Criteria:

Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic.
Able to provide written informed consent to participate.
Must be the age of 18 years of age or older.
Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.

Exclusion Criteria:

Patients with eye surgery in the prior six months.
Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
Patients with pre-existing anterior chamber inflammation.
Patients with known sensitivity to any of the study medications.
Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
Intervention: PREDNISOLONE ACETATE
Trial phase: Not Applicable
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days

Pred Forte: Details covered in arm description
Eligibility criteria:
Inclusion Criteria:

Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic.
Able to provide written informed consent to participate.
Must be the age of 18 years of age or older.
Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.

Exclusion Criteria:

Patients with eye surgery in the prior six months.
Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
Patients with pre-existing anterior chamber inflammation.
Patients with known sensitivity to any of the study medications.
Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
Intervention: Urovision
Trial phase: Phase 4
SMILES: CC(=O)Nc1c(I)c(NC(C)=O)c(I)c(C(=O)O)c1I.CC(=O)Nc1c(I)c(NC(C)=O)c(I)c(C(=O)[O-])c1I.CNCC(O)C(O)C(O)C(O)CO.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 300
Group description: Oral Gastroview prior to CT
Eligibility criteria:
Inclusion Criteria:

Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with the patient's provider will be screened for eligibility.

Exclusion Criteria:

Not competent to give consent.
Pregnant.
Known allergy to either of the contrast agents.
Loss of sense of taste or smell.
Contraindication to oral administration such as aspiration risk.
Intervention: Iohexol
Trial phase: Phase 4
ATC code: V08AB02
SMILES: CC(=O)N(CC(O)CO)c1c(I)c(C(=O)NCC(O)CO)c(I)c(C(=O)NCC(O)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 300
Group description: Oral Omnipaque prior to CT
Eligibility criteria:
Inclusion Criteria:

Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with the patient's provider will be screened for eligibility.

Exclusion Criteria:

Not competent to give consent.
Pregnant.
Known allergy to either of the contrast agents.
Loss of sense of taste or smell.
Contraindication to oral administration such as aspiration risk.
Intervention: Vardenafil hydrochloride trihydrate
Trial phase: Phase 2
SMILES: CCCc1nc(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(CC)CC4)ccc3OCC)nn12.Cl.O.O.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 198
Group description: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Male and female patients aged > 18 years (females either postmenopausal or using adequate birth control)

Urodynamic criteria:

Entire bladder capacity (= maximum cystometric bladder capacity) < 300 mL OR
In accordance with International Continence Society (ICS)-guidelines: Detrusor overactivity as defined as spontaneous involuntary detrusor contraction during filling phase OR
Detrusor contraction during filling phase leading to involuntarily initiated micturition before a normal bladder capacity is reached
Patient micturition diary criteria: at least 8 micturitions per day AND at least 1 urgency episode per day
Signed and dated written Patient Informed Consent Form

Exclusion Criteria:

Treatment with drugs known to affect urinary bladder function
Known other reasons for micturition problems than detrusor overactivity
Recent intervention in urogenital tract
Abnormal liver or renal lab values
Treatment with nitrates or nitric oxide donors, alpha-blockers, potent inhibitors of CYP-450 3A4, acenocoumarol, heparin, drugs known to prolong QT-interval
NAION, hereditary regenerative retinal disorders, severe cardiovascular conditions, recent history of myocardial infarction/stroke/life-threatening arrhythmia
congenital QT-prolongation, left ventricular outflow obstruction, severe hypo- or hypertension, symptomatic postural hypotension
History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C
Significant active peptic ulceration
Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
In men: Clinically significant chronic haematological disease which may lead to priapism
History of malignancy of any organ system within the past 5 years
Bleeding disorder
Intervention: Plerixafor
Trial phase: Phase 1 | Phase 2
ATC code: L03AX16
SMILES: c1cc(CN2CCCNCCNCCCNCC2)ccc1CN1CCCNCCNCCCNCC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: AMD3100: 240 mcg/kg subcutaneously, minimum of two days; maximum of eight days

AmCell CliniMACs: CD34+ cell selection from peripheral collection
Eligibility criteria:
Inclusion Criteria:

Patients must have had a diagnosis of Fanconi anemia confirmed by a positive test for increased chromosomal breakage with mitomycin C or diepoxybutane from peripheral blood, bone marrow or amniotic fluid.
Bone marrow biopsy/aspirate with cellularity (mononuclear cells per ml of bone marrow obtained), CD34+ content (% of MNC), and normal cytogenetics within three months of collection.
For the first two cohorts: Absolute neutrophil count > 750/mm3, Hemoglobin > 8 gm/dl without transfusion, platelet count > 50,000/mm3 without transfusion (within 30 days prior to bone marrow collection or PB stem cell mobilization). For the final cohort, the platelet count will be >30,000/mm3 without transfusion (within 30 days prior to bone marrow collection or PB stem cell mobilization).
Minimum weight: 7.5 kg.

Age:

First cohort - > 7 Second cohort - > 3 Third cohort - >1.

Ability of patient or parent/legal guardian to consent for bone marrow harvest.
Ability of patient or parent/legal guardian to consent for placement of temporary apheresis catheter.
Ability of patient or parent/legal guardian to consent for apheresis collection.
Ability of patient or parent/legal guardian to consent for PRBC/platelet transfusions.

Exclusion Criteria:

Myeloid or lymphoid leukemia.
Clonal cytogenetic abnormality of bone marrow or peripheral blood lymphocytes (in >2 metaphases by G-banded karyotype or any chromosome deletions of chromosome 7 by Fluorescence in situ hybridization or FISH).
Pregnancy or lactation. Women with childbearing potential who are to be collected will be advised that the marrow harvest procedure or the risk of G-CSF used for stem cell mobilization may be teratogenic and will be required to take adequate measures to prevent contraception.
Concurrent enrollment in any study using an investigational drug (defined as a drug not approved by the FDA) with the exception of androgens or thyroxine.
Physical or emotional status that would prevent compliance, ability to understand treatment plan or adequate follow-up.
HIV positive patients.
Patients with neoplastic or non-neoplastic disease of any major organ system that would compromise their ability to withstand the bone marrow harvest or apheresis procedure.
Patients with uncontrolled (culture or biopsy positive) infection requiring intravenous antivirals, antibiotics, or antifungals. Patients on prolonged antifungal therapy are still eligible if they are culture or biopsy negative in residual radiographic lesions, and they meet the other organ function criteria.
Patients unable to tolerate general anesthesia.
Known adverse reaction to E. coli products or G-CSF and any contraindication to leukocytosis or hypocalcemia or (where indicated) central line placement.
Intervention: Tredaptive
Trial phase: Phase 3
SMILES: CS(=O)(=O)c1cc(F)cc2c3c(n(Cc4ccc(Cl)cc4)c12)C(CC(=O)O)CC3.O=C(O)c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 602
Group description: One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
Eligibility criteria:
Inclusion Criteria:

Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion Criteria:

Patient whose LDL-C values are not within protocol specified range
Intervention: Navitoclax
Trial phase: Phase 1 | Phase 2
ATC code: L01XX78
SMILES: [H][C@@](CCN1CCOCC1)(CSc1ccccc1)Nc1ccc(S(=O)(=O)NC(=O)c2ccc(N3CCN(CC4=C(c5ccc(Cl)cc5)CCC(C)(C)C4)CC3)cc2)cc1S(=O)(=O)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.
Eligibility criteria:
Inclusion Criteria:

Relapsed or refractory CLL and require treatment in opinion of investigator.
Eastern Cooperative Oncology Group (ECOG) <= 1.
Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

Exclusion Criteria:

History or is clinically suspicious for cancer-related Central Nervous System disease.
Receipt of allogenic or autologous stem cell transplant.
Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).
Intervention: Navitoclax
Trial phase: Phase 1 | Phase 2
ATC code: L01XX78
SMILES: [H][C@@](CCN1CCOCC1)(CSc1ccccc1)Nc1ccc(S(=O)(=O)NC(=O)c2ccc(N3CCN(CC4=C(c5ccc(Cl)cc5)CCC(C)(C)C4)CC3)cc2)cc1S(=O)(=O)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Navitoclax 100 mg in subjects with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
Eligibility criteria:
Inclusion Criteria:

Relapsed or refractory CLL and require treatment in opinion of investigator.
Eastern Cooperative Oncology Group (ECOG) <= 1.
Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

Exclusion Criteria:

History or is clinically suspicious for cancer-related Central Nervous System disease.
Receipt of allogenic or autologous stem cell transplant.
Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).
Intervention: Modafinil
Trial phase: Phase 2
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
Eligibility criteria:
Key Inclusion Criteria:

The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
The patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid.

Key Exclusion Criteria:

The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence).
The patient has any clinically significant uncontrolled medical or surgical condition.
The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
Intervention: Estradiol
Trial phase: Phase 2
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: IVIg alone

intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles
Eligibility criteria:
Inclusion Criteria:

Lesions consistent with pemphigus foliaceus or vulgaris
Diagnosis confirmed by histology and IIF ≥ 40 within past month
On ≥20mg/day of prednisone per day for two weeks or ≥ 80mg/day for one week
Women of childbearing potential negative HCG obtained two weeks prior to first IVIg
Agrees to two acceptable forms of contraception* if randomized to cyclophosphamide group:
IUD (except progesterone T), Combination oral contraceptives, transdermal patch, vaginal ring, hormonal injectables or implantables, male latex condom, diaphragm, cervical cap, or vaginal sponge (contains spermicide)
Normal organ function confirmed by CBC, UA, LFTs and Ig levels within defined inclusion criteria
Responds yes to at least one of the criteria below:
Persistence of clinical manifestations of disease despite steroid treatment
Flare in disease activity after an attempt at steroid tapering
Failure of established lesions to heal
Rapidly progressive disease.
Conventional therapy is relatively contraindicated i.e. side effects, co-morbid conditions
systemic infections, peptic ulcers, osteoporosis, hypertension, cataracts or others

Exclusion Criteria:

Use of IVIg within past 3 weeks or the use of a cytotoxic drug within the past 2 weeks
Participating in another clinical trial at the time of screening and enrollment
Medical condition that precludes use of IVIg or cyclophosphamide (i.e. pregnancy breastfeeding, underlying chronic infection, concurrent opportunistic infection, sepsis or volume depletion
Renal insufficiency ( GFR <90, proteinuria (>1+, x 2), creatinine >1.8 or increased WBC or RBCs which cannot be explained by cystitis.)
Known hypersensitivity to study drugs, IVIg or cyclophosphamide
Intervention: Ziprasidone
Trial phase: Phase 3
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
Eligibility criteria:
Inclusion Criteria:

Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

Exclusion Criteria:

Patients with ultra-fast rapid cycling (8 or more mood episodes per year)
Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
Psychotic symptoms (hallucinations and/or delusions).