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Decision-Making in Bipolar Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Boadie W. Dunlop, Emory University
ClinicalTrials.gov Identifier:
NCT01463111
First received: June 2, 2011
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

Forty subjects with bipolar disorder who are not receiving a mood-stabilizing medication for the treatment of their illness will participate in this study. The study aims to evaluate how decision-making is affected by treatment for bipolar disorder. Prior to beginning treatment, patients will complete questionnaires and a one-hour computer-administered assessment of decision-making. Differences between pre-post decision-making outcomes will be evaluated to examine whether the neuroeconomic concepts of risk aversion, loss aversion, risk tolerance and delay discounting are affected by treatment.

The overall goal of this study will be to identify whether decision-making in people with bipolar disorder is affected by treatment. Specifically the investigators will compare decision-making characteristics among bipolar patients prior to treatment with how these decision-making characteristics change over the course of 6 weeks of standard medication therapy for bipolar disorder. A total of 6 decision-making tasks and one control task will be administered via computer to eligible subjects. The investigators will evaluate decision-making under varying conditions of reward, risk, and uncertainty and over time. The investigators hypothesize that decision-making will improve across these assessments after 6 weeks of treatment.


Condition Intervention
Bipolar Disorder
Drug: Lithium, valproate, lamotrigine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Decision-Making in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Delay Equivalent [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Temporal discounting refers to the tendency to place less value on a reward as it moves away from the present time. Subjects will make decisions about whether to accept an immediate gain or loss verus a gain or loss occurring at some point in the future. Several iterations of choices are made using differing time frames. The results of these choices are then used to calculate the delay equivalent value.


Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mood stabilizer
Monotherapy treatment with either valproate, lithium or lamotrigine
Drug: Lithium, valproate, lamotrigine
Open label treatment per standard of care for bipolar disorder
Other Names:
  • Lithium
  • Eskalith
  • Valproic acid
  • Valproate
  • Depakote
  • Lamotrigine
  • Lamictal

Detailed Description:

Participation in this study will require three study visits over 6 weeks. Subjects will be evaluated with the Structured Diagnostic Interview for DSM-IV to confirm diagnosis. They will also be administered the Hamilton Anxiety and Depression Rating Scales. Eligible subjects will then complete questionnaires related to their symptoms as well as decision-making and risk-taking, including: the Barratt Impulsiveness Scale, the Spielberger State-Trait Anxiety Inventory, and the Flinders Decision-making questionnaire. The Montgomery-Asburg Depression Severity scale to assess changes in depression symptom severity and the Young Mania Rating Scale to assess changes in manic symptom severity, will be conducted at screening, baseline, and endpoint. Patients will also be given the Childhood Trauma Questionnaire at baseline visit, to assess for a history of childhood trauma. The subjects will then complete the computer-generated decision-making tasks. Upon completion, the study physician will initiate standard-of-care treatment with a mood stabilizer (either lithium, valproate, or lamotrigine). Standard-of-care laboratory testing and psychiatric follow-up will be performed during the patient's study participation. After six weeks of treatment with a mood stabilizer, patients will again complete the decision-making computerized assessment.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female, age 18-65
  2. Primary DSM-IV TR Diagnosis of Bipolar Disorder, type I, II or NOS.
  3. Ability to visually read and understand English language
  4. Not currently taking any mood stabilizer or antipsychotic medication.
  5. Women of reproductive potential must be willing to take a medically approved form of birth control throughout the duration of the study.

Exclusion Criteria:

  1. Meet criteria for substance abuse or dependence within three months of the screening visit.
  2. Presents with a clinically significant suicide risk, as assessed by a study physician.
  3. Presence of any unstable or central nervous system-related medical illness that would interfere with cognition or participation.
  4. Women who are currently pregnant or lactating, or plan to become pregnant during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463111

Locations
United States, Georgia
Emory University Mood and Anxiety Disorders Program Recruiting
Atlanta, Georgia, United States, 30306
Contact: Alison Oliver, MA    404-712-5095    alison.oliver@emory.edu   
Contact: Valerie Cruz    404-727-8474    vcruz@emory.edu   
Principal Investigator: Boadie Dunlop, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Boadie W Dunlop, MD Emory University
  More Information

No publications provided

Responsible Party: Boadie W. Dunlop, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01463111     History of Changes
Other Study ID Numbers: IRB00050442, BDDM
Study First Received: June 2, 2011
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Bipolar
Manic depression
Mood stabilizer
Decision
Neuroeconomics

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Anticonvulsants
Lamotrigine
Lithium
Lithium Carbonate
Valproic Acid
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sodium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014