- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00186186
Depakote ER in Bipolar Depression
Study Overview
Detailed Description
Mood disorders are important public health problems. Bipolar disorder is a major psychiatric disorder characterized by mood cycles alternating between mania and depression and affects approximately 1% of the population. Most patients are treated beginning in the early twenties and then embark on a course marked by multiple recurrences, hospitalizations, and encounters with legal authorities. These disorders inflict substantial morbidity which yields important deficits in occupational and interpersonal function. The risk of suicide in mood disorders may be as high as 10%.
Although the outlook for recovery from acute manic or depressive episodes is generally excellent, the long-term prognosis of the disorder varies tremendously across the patient population. The introduction of lithium, anticonvulsants and atypical antipsychotics significantly changes the outlook for bipolar disorder, with some individuals on chronic treatment attaining complete remission and indefinite prophylaxis against mood episodes. However, such optimum outcomes may be limited to as few as one-third to one-half of all treated patients. The remaining experiences various combinations of breakthrough mood episodes, including chronic mood instability, persistent depression, and rapid cycling.
Very little research has been conducted with bipolar disorder, and no medications have an FDA indication to treat bipolar depression. Previous studies suggest that Depakote is promising in the treatment of mixed and depressed episodes of bipolar disorder. This study utilizes the extended release formulation of divalproex sodium, with demonstrated increased tolerability.
We propose investigating safety, tolerability and efficacy of Depakote ER monotherapy in Bipolar I, II or NOS depression, and monitoring associated changes in brain GABA levels. In addition, we intend to evaluate and assess the differences between brain metabolic rate and GABA levels in bipolar disorder patients and healthy volunteers.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305-5723
- Stanford University Bipolar Disorders Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Bipolar I, II or NOS currently suffering from depression
- Both: both female and male participants are being studied
- Adults 18 years and older of any race
Exclusion Criteria:
- Schizophrenia or schizoaffective disorder and other disorders excluded at the discretion of the investigator's discretion
- Substance dependence within the past 3 months and abuse within the past 2 weeks prior to study.
- Positive screen for psychoactive drugs, stimulants or drugs of abuse (excluding marijuana, as long as dependence and abuse are ruled out according to DSM-IV)
- Significant risk harm to self or others based on history and mental status exam
- Clinically significant or unstable medical condition
- Unstable thyroid pathology and treatment initiated or altered within the past 3 months
- Clinically significant abnormal laboratory test results, vital signs, as judged by the investigators
- Women pregnant or nursing, or WOCBP who do not use adequate contraception or who are judged to be unreliable in their use of contraception
- Subjects who failed (because of inefficacy or adverse effects) an adequate trial of Depakote; eligible patient's may not have received Depakote within 30 days of screen
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Depakote ER
Depakote ER up to 1500 mg/day
|
Depakote ER
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline, 7 weeks
|
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression. |
Baseline, 7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to the Divalproex-ER in Acute Bipolar 2 Depression.
Time Frame: 7 weeks
|
A reduction greater than or equal to 50% in MADRS total score from baseline to the endpoint.
|
7 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Terence A. Ketter, MD, Stanford University, Department of Psychiatry and Behavioral Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Bipolar and Related Disorders
- Depression
- Depressive Disorder
- Bipolar Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
Other Study ID Numbers
- 79130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression, Bipolar
-
University Health Network, TorontoCompletedBipolar Disorder | Bipolar Depression | Bipolar I Depression | Bipolar II DepressionCanada
-
Forest LaboratoriesGedeon Richter Ltd.CompletedDepression, BipolarUnited States, Ukraine, Bulgaria, Canada, Colombia, Russian Federation
-
Queen's UniversityPfizer; Providence Health & Services; MDS Pharma ServicesCompletedDepression, BipolarCanada
-
Brigham and Women's HospitalRecruitingDepression | Bipolar Disorder | Bipolar Depression | Major Depressive Episode | Bipolar I Depression | Bipolar II DepressionUnited States
-
Ewha Womans University Mokdong HospitalWithdrawnDepression, BipolarKorea, Republic of
-
AstraZenecaCompletedAcute Bipolar DepressionBrazil, Mexico, Peru, Turkey, Argentina, Chile, Venezuela, Colombia, Guatemala
-
Mclean HospitalTerminatedBipolar Depression Depressed PhaseUnited States
-
Valerie TaylorUniversity Health Network, TorontoActive, not recruitingBipolar DepressionCanada
-
National University of Ireland, Galway, IrelandStanley Medical Research InstituteCompletedBipolar DepressionIreland
-
Astellas Pharma IncCompleted
Clinical Trials on Depakote ER
-
AbbottCompletedPediatric EpilepsyUnited States
-
University Hospitals Cleveland Medical CenterAbbottCompleted
-
Massachusetts General HospitalAbbottCompletedMania | Mixed ManiaUnited States
-
Medical University of South CarolinaWithdrawnGlioma | Glioblastoma | Medulloblastoma | Anaplastic Astrocytoma | Pediatric Brain TumorUnited States
-
University Hospitals Cleveland Medical CenterAbbottCompletedBipolar DisorderUnited States
-
University of CincinnatiAbbottWithdrawnBehavioral Symptoms | Dementia | Alzheimer's DiseaseUnited States
-
University of California, San DiegoAbbottCompleted
-
Cambridge Health AllianceNorthwestern UniversityCompletedBipolar Disorder
-
Palo Alto Veterans Institute for ResearchNational Institute of Mental Health (NIMH)Completed
-
State University of New York - Upstate Medical...CompletedBladder Cancer | HematuriaUnited States