Trial record 19 of 514 for:    Open Studies | antidepressants

Neuroimaging Predictors of Antidepressant Treatment Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Marta Pecina Iturbe, University of Michigan
ClinicalTrials.gov Identifier:
NCT02000726
First received: October 24, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

Current medical therapies for depression take weeks to achieve full efficacy, and are ineffective in many patients or cause intolerable side effects, emphasizing the need for a deeper understanding of depression and its treatment. Identifying early brain biomarkers of treatments responses seems necessary to improve antidepressant treatment outcome. In this study we aim to detect early brain responses to a fast acting antidepressant-like treatment administered intravenously during a Real-Time Neurofeedback functional magnetic resonance imaging (MRI) Task to predict antidepressant treatment outcome in depression. At completion of the neuroimaging task, participants will enter a placebo-controlled clinical trial with a selective serotonin reuptake inhibitor (SSRI).


Condition Intervention Phase
Depression
Drug: Placebo
Drug: Citalopram
Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Blood-oxygen-level dependent (BOLD) responses during the Real-Time Neurofeedback Task. [ Time Frame: BOLD responses will be assessed at baseline and depression severity will be assessed at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression severity assessed with several depressive questionnaires. [ Time Frame: Every two weeks until the end of the trial (16 weeks total), or until the participants leave the study. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Neuropsychological functioning of patients with depression [ Time Frame: At baseline ] [ Designated as safety issue: No ]

    Affect processing: Emotional Words Task and Facial Emotion Perception test. Attention and Inhibitory Control: Parametric Go/NoGo, Trail Making test and the Stroop Color Word test .

    Inferential Reasoning (including cost-benefit analysis): Delayed Discounting of Money Rewards, Iowa Gambling Task, Common Difference effect gambling task and the WCST.


  • BDNF Val66Met single nucleotide polymorphism(SNP)genotyping [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    5ml of blood drawn per participants will be used for genotyping


Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo and Citalopram
4 weeks of 1 placebo pill/day and 12 weeks of citalopram 20-40 mg/day
Drug: Placebo Drug: Citalopram
Other Name: Celexa
Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session
Fast acting antidepressant-like treatment administered intravenously for 35 min. during the fMRI scanning session.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria will include Hamilton Depressive Rating Scale (HDRS) scores >15 and Snaith-Hamilton Pleasure Scale scores (SHAPS) > 7.

Exclusion Criteria:

suicidal ideation, comorbid conditions that are medical, neurological or psychiatric, pregnancy, use of hormones (including birth control) or use of psychotropic agents. We will only permit certain past anxiety disorder diagnoses, including generalized anxiety, panic, agoraphobia, social phobia.

We will also exclude left-handed individuals and patients who have used any centrally acting medications, nicotine, or recreational drugs within the past 2 months.

  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: NCT02000726

Contacts
Contact: Erich Avery 7346157218 erichave@med.umich.edu

Locations
United States, Michigan
Department of Psychiatry Recruiting
Ann Arbor, Michigan, United States, 48108
Contact: Erich Avery    734-615-7218    erichave@med.umich.edu   
Principal Investigator: Marta Pecina Iturbe, MD PhD         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Marta Pecina Iturbe, MD PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT02000726     History of Changes
Other Study ID Numbers: HUM00073082
Study First Received: October 24, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Second-Generation
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 24, 2014