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Neuroimaging Predictors of Antidepressant Treatment Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02000726
Recruitment Status : Withdrawn (Lack of funding to complete the trial phase of the study.)
First Posted : December 4, 2013
Last Update Posted : November 21, 2016
Information provided by (Responsible Party):
Marta Pecina Iturbe, University of Michigan

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Drug: Placebo Drug: Citalopram Drug: Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Study Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]

Other Outcome Measures:
  1. Neuropsychological functioning of patients with depression [ Time Frame: At baseline ]

    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.

  2. BDNF Val66Met single nucleotide polymorphism(SNP)genotyping [ Time Frame: At baseline ]
    5ml of blood drawn per participants will be used for genotyping

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02000726

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United States, Michigan
Department of Psychiatry
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
University of Michigan
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Responsible Party: Marta Pecina Iturbe, MD PhD, University of Michigan Identifier: NCT02000726    
Other Study ID Numbers: HUM00073082
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Behavioral Symptoms
Antidepressive Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Psychotropic Drugs