Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
- Registration Number
- NCT01072630
- Lead Sponsor
- Cephalon
- Brief Summary
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 492
- The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
- Documentation that the patient has had at least 1 previous manic or mixed episode.
- The patient has had no more than 6 mood episodes in the last year.
- The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
- The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid).
- Written informed consent is obtained.
- The patient is a man or woman 18 through 65 years of age.
- The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry, hematology, and urinalysis.
- Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
- The patient has permanent accommodations and means of being contacted by the study center.
- The patient understands that they may enroll in this clinical study only once and may not enroll in any other clinical study while participating in this trial.
- The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
- The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
- The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
- The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.
- The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period.
- The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies.
- The patient has any clinically significant uncontrolled medical condition, treated or untreated.
- The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets.
- The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study.
- The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit.
- The patient is a pregnant or lactating woman.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks. Armodafinil 150 mg/day Armodafinil Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. Armodafinil 200 mg/day Armodafinil Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) Day 0 (baseline), Week 8 The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
- Secondary Outcome Measures
Name Time Method Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16) Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.
Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks) The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.
Participants With Treatment-Emergent Adverse Events (TEAE) Day 1 to Week 9 AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.
Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks) HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.
Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks) The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.
.Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks) The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks) The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.
The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.
Trial Locations
- Locations (91)
Paarl Medical Centre
🇿🇦Paarl, South Africa
Psychiatric clinic for women UMHAT "Dr. Georgi Stranski"
🇧🇬Pleven, Bulgaria
B.A. Psychiatric Research Cent
🇦🇷Buenos Aires, Argentina
Centro de Investigación y asistencia en Psiquiatria (CIAP)
🇦🇷Rosario, Argentina
Hospital del Henares
🇪🇸Coslada (Madrid), Spain
Hospital Santiago Apostol
🇪🇸Vitoria, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Spain
Hospital Psiquiátrico de Álava
🇪🇸Vitoria-Gasteiz, Spain
Dr Magnus & Dr Brink
🇿🇦Johannesburg, South Africa
Dey Clinic
🇿🇦Pretoria, South Africa
ODPZS- EOOD, Plovdiv, Bulgaria
🇧🇬Plovdiv, Bulgaria
Flexivest Fourteen Research Centre
🇿🇦Cape Town, South Africa
Comprehensive NeuroScience
🇺🇸Washington DC, District of Columbia, United States
Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie
🇵🇱Gdansk, Poland
Cape Trial Centre
🇿🇦Cape Town, South Africa
Vista Clinic
🇿🇦Centurion, South Africa
Knighton Surgery
🇿🇦Cape Town, South Africa
Public Institution "Institute of Neurology, Psychiatry and N
🇺🇦Kharkiv, Ukraine
Hawaii Clinical Research Center
🇺🇸Honolulu, Hawaii, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
North County Clinical Research
🇺🇸Oceanside, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Viking Clinical Research Center
🇺🇸Temecula, California, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Fieve Clinical Services, Inc.
🇺🇸New York, New York, United States
Medical and Behavioral Health Research
🇺🇸New York, New York, United States
Behavioral Medical Research of Brooklyn
🇺🇸Brooklyn, New York, United States
Midwest Center for Neurobehavioral Medicine
🇺🇸Oakbrook Terrace, Illinois, United States
Community Research
🇺🇸Crestview Hills, Kentucky, United States
North Coast Clinical Trials, Inc.
🇺🇸Beachwood, Ohio, United States
University Hills Clinical Research
🇺🇸Irving, Texas, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Alliance Research Group
🇺🇸Richmond, Virginia, United States
Insite Clinical Research
🇺🇸Desoto, Texas, United States
CMP/CHS du Jura
🇫🇷Dole, France
Malopolskie Centrum Medyczne
🇵🇱Krakow, Poland
Danylo Galitsky Lviv State Medical University
🇺🇦Lviv, Ukraine
Clinical Neuroscience Solutions Inc
🇺🇸Jacksonville, Florida, United States
CRI Worldwide, LLC
🇺🇸Mount Laurel, New Jersey, United States
Fidelity Clinical Research
🇺🇸Lauderhill, Florida, United States
Sanatorio Prof. León S. Morra SA
🇦🇷Córdoba, Argentina
INECO
🇦🇷Buenos Aires, Argentina
Instituto FLENI
🇦🇷Buenos Aires, Argentina
Neurotherapy Victoria Clinical Trials
🇦🇺Malvern, Victoria, Australia
MHAT - Sveta Marina
🇧🇬Varna, Bulgaria
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Grey Nuns Hospital
🇨🇦Edmonton, Alberta, Canada
District Department of Psychiatric Disorders With Stationary
🇧🇬Bourgas, Bulgaria
State Psychiatric Hospital - Pazardjik
🇧🇬Pazardjik, Bulgaria
Hopital Universitaire Caremeau-Batiment Polyvalent, Service
🇫🇷Nîmes, France
Aspen Clinical Research, LLC
🇺🇸Orem, Utah, United States
Dr. Gregorio Hugo Sorin
🇦🇷Buenos Aires, Argentina
MHAT Doverie
🇧🇬Sofia, Bulgaria
Psychiatric clinic, University Hospital "Alexandrovska"
🇧🇬Sofia, Bulgaria
Centre Hospitalier de Jonzac
🇫🇷Jonzac, France
Kiev City Psychoneurological Hospital N 1, CNTRP
🇺🇦Kiev, Ukraine
Vinnytsa National Medical University named by M.I. Pirogov
🇺🇦Vinnitsa, Ukraine
Dr. Alexander McIntyre, Inc.
🇨🇦Penticton, British Columbia, Canada
Northern Area Mental Health Services Northern Psychiatric R
🇦🇺Melbourne, Victoria, Australia
Hôpital Louis Hlafontaine
🇨🇦Montreal, Quebec, Canada
Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM
🇵🇱Gdansk, Poland
Diagnostic Consultative Center "Tchaika"
🇧🇬Varna, Bulgaria
Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Odessa Regional Psychoneurology Dispensary
🇺🇦Odessa, Ukraine
Odessa Regional Mental Hospital #2
🇺🇦s. Oleksandrivka, Odessa, Ukraine
Donetsk National Medical University n.a. M. Horkyy
🇺🇦Donetsk, Ukraine
Birmingham Psychiatry Pharmaceutical Studies, Inc
🇺🇸Birmingham, Alabama, United States
Stedman Clinical Trials, LLC
🇺🇸Tampa, Florida, United States
AccelRx Research
🇺🇸Fall River, Massachusetts, United States
Belmont Center for Comprehensive Treatment
🇺🇸Philadelphia, Pennsylvania, United States
Sun Valley Behavioral Medical
🇺🇸Imperial, California, United States
South Coast Medical Associates/SC Clinical Trials, Inc.
🇺🇸Anaheim, California, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
CNRI Los Angeles LLC
🇺🇸Pico Rivera, California, United States
CNRI-San Diego LLC
🇺🇸San Diego, California, United States
Clinical Innovations Inc.
🇺🇸Santa Ana, California, United States
Scientific Clinical Research, Inc.
🇺🇸Aventura, Florida, United States
Florida Clinical Research Center
🇺🇸Bradenton, Florida, United States
CNS - Comprehensive Neuro Science
🇺🇸Park Ridge, Illinois, United States
Behavioral Medical Research of Staten Island
🇺🇸Staten Island, New York, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Neuro-Behavioral Clinical Research, Inc
🇺🇸Canton, Ohio, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Mayo College of Medicine
🇺🇸Rochester, Minnesota, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.)
🇺🇸Portland, Oregon, United States
Providence Care Mental Health Services
🇨🇦Kingston, Ontario, Canada
Red Oak Psychiatry Associates, P.A.
🇺🇸Houston, Texas, United States
Clinical Methods
🇺🇸Salt Lake City, Utah, United States
Medical Research Associates
🇨🇦Mississauga, Ontario, Canada