Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging

NCT02473250 | Completed Phase 4 Results

• 1 other identifier: #7056
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for subjects with a diagnosis of bipolar disorder who have depression at the time of recruitment. It involves brain imaging with an MRI (magnetic resonance imaging) and PET scan (positron emission tomography) and treatment with an antidepressant. The medication involves adding an SSRI (either celexa/citalopram or prozac/fluoxetine) to a mood stabilizer.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  Depression severity. Minimum=0, Maximum=60. Higher numbers correspond to greater depression severity. The percent change between week 0 and the last observation was calculated.

  6 weeks

Secondary Outcomes (3)

• Hamilton Anxiety Rating Scale

  6 weeks

• Young Mania Rating Scale

  6 weeks

• Clinical Global Impression-1

  6 weeks

Study Arms (1)

Bipolar depressed

EXPERIMENTAL

Bipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate)

Drug: Fluoxetine; Drug: Citalopram

Interventions

Fluoxetine DRUG

Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate).

Also known as: Prozac

Bipolar depressed

Citalopram DRUG

Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted.

Also known as: Celexa

Bipolar depressed

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide informed consent
• Diagnosis of bipolar I disorder or bipolar II disorder and currently meet criteria for a major depressive episode
• Patients who were on psychiatric medication at presentation will have failed that regimen, as defined as not achieving at least partial remission after an adequate dose of medication for at least six weeks.
• Depression of sufficient severity to score at least 16 on the first 17 items of the Hamilton Depression Rating Scale
• Age range 18-60 years
• Females of child-bearing potential must be willing to use an acceptable method of birth control throughout the study.
• Subject agrees to discontinue all psychotropic other than those in the PSF and other types of drugs likely to interact with the 5-HT1A receptors.
• Subject is likely to tolerate medication cross-taper to monotherapy with a mood stabilizer (valproate, lamotrigine or lithium).

You may not qualify if:

• Diagnosis of any other major psychiatric disorders such as lifetime schizophrenia, schizoaffective disorder, current psychotic depression or current drug or alcohol abuse (within two months before the study) or recent drug or alcohol dependence (within six months before the study); anorexia nervosa or bulimia nervosa within the last year; IV drug use of ecstasy use more than three times. Meet criteria for a manic episode at the time of screening.
• Previous failed trial of fluoxetine and citalopram by themselves or in combination with an anti-manic agent, defined as at least six weeks of treatment at the dose of 20 mg per day or more. Failure of two trials of any SSRI or SNRI antidepressant medications.
• If the patients are discontinuing medications as part of the washout period or are starting valproate, previous failed trial of mood stabilizer that they will take alone.
• Experienced intolerable side effects of both citalopram and fluoxetine in the past. If the subject is not on medications, intolerable side effects of valproate in the past.
• History of clinical deterioration when any of the medications that the patient is taking at presentation have been discontinued in the past with the exception of any medications that will be continued during the research protocol.
• A first-degree family history of schizophrenia if the subject is less than 33 years old
• Significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, malignancy
• Actively suicidal, as defined by expressing ideation with a plan for suicide or develops suicidal ideation that requires immediate medication or treatment intervention.
• Pregnancy, abortion or miscarriage in the two months prior to enrollment or plans to conceive during the course of study participation
• Lactating women
• ECT within the past 6 months
• Subjects who endorse a history of prior head trauma and score 1.5 standard deviations below the mean on Trail-making A \& B will be excluded from study participation.
• Metal implants, pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body
• Current, past or anticipated exposure to radiation, including:
• Having been badged for radiation exposure in the workplace

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute/Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• Lan MJ, Pantazatos SP, Ogden RT, Rubin-Falcone H, Hellerstein D, McGrath PJ, Mann JJ. Resting State MRI Amplitude of Low Frequency Fluctuations Associated With Suicidal Ideation in Bipolar Depression. J Clin Psychiatry. 2022 Mar 30;83(3):21m14054. doi: 10.4088/JCP.21m14054.

  PMID: 35377567 DERIVED

• Lan MJ, Zanderigo F, Pantazatos SP, Sublette ME, Miller J, Ogden RT, Mann JJ. Serotonin 1A Receptor Binding of [11C]CUMI-101 in Bipolar Depression Quantified Using Positron Emission Tomography: Relationship to Psychopathology and Antidepressant Response. Int J Neuropsychopharmacol. 2022 Aug 4;25(7):534-544. doi: 10.1093/ijnp/pyac001.

  PMID: 34996114 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Fluoxetine; Citalopram

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Martin Lan MD PhD
• Organization: Columbia University Irving Medical Center

martin.lan@nyspi.columbia.edu

646 774 7610

Study Officials

• Martin Lan, MD PHD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychiatrist

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 16, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 31, 2024
• Results First Posted: April 1, 2021

Record last verified: 2024-12

Locations

US (1)