Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

• ClinicalTrials.gov Identifier: NCT00562861
• Recruitment Status: Completed
• First Posted: November 22, 2007
• Results First Posted: February 13, 2017
• Last Update Posted: March 24, 2017
• Sponsor: Tufts Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Tufts Medical Center

Study Description

Brief Summary:

Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in treating bipolar depression when taken with a mood stabilizer medicine.

The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the treatment of major depression, but is not FDA approved for the treatment of bipolar depression. It is, however, standard practice for many doctors is to use antidepressants, like Celexa, to treat their patients with bipolar disorder depression.

The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at the possibility that there may be a gene that could predict if a person would get better taking the drug using genetics.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder; Bipolar Depression	Drug: citalopram + mood stabilizer; Drug: placebo + mood stabilizer	Phase 2; Phase 3

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 119 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
• Study Start Date: November 2007
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: citalopram + mood stabilizer; All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to citalopram.	Drug: citalopram + mood stabilizer; Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d. No target dose will be provided but rather clinicians will dose to clinical efficacy. Thus the study will provide clinicians data on the effective dose if it is positive. The dose will not be predetermined at static amounts.; Other Name: Celexa
Placebo Comparator: placebo + mood stabilizer; All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to placebo	Drug: placebo + mood stabilizer; This arm will only receive mood stabilizing medication. All subjects will be required to receive treatment with lithium, lamotrigine, valproate, or carbamazepine for at least one month at therapeutic blood levels or doses before randomization, or they must initiate one of these agents at study entry.; Other Name: lithium, lamotrigine, valproate, or carbamazepine

Outcome Measures

Primary Outcome Measures :

1. MADRS Rating Scale Change [ Time Frame: 6 weeks ]
   Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Current age ≥18 years
• DSM-IV diagnosis of BPD, type-I, or type-II
• Current major depressive episode using DSM-IV criteria, lasting 8 weeks or longer.
• Use of lithium, divalproex, carbamazepine, or lamotrigine at therapeutic serum levels or doses for ≥4 weeks prior to study entry, or willingness to accept one of these agents.
• Prior to initial evaluations, each subject must provide competent, written, informed consent.

Exclusion Criteria:

• Past non-response to a therapeutic trial of R,S-citalopram (≥100 mg/day for ≥8 weeks).
• Previous intolerance of R,S-citalopram;
• Diagnosis of unipolar depression
• Diagnosis of schizoaffective disorder
• Serious medical illness with acute instability (cardiac, respiratory, hepatic, renal), based on hospitalization in the past month
• Abnormal thyroid function tests
• Previous allergic reaction to or inability to tolerate lithium, divalproex, or carbamazepine at therapeutic serum levels.
• Current or past renal dysfunction if taking lithium
• Current or past hepatitis or other liver disease if taking divalproex
• Current or past hematologic disease if on carbamazepine
• Severe suicidal ideation, plan or intent, as documented by a score of ≥4 on the Montgomery Åsberg Depression Rating Scale suicidality item (Item 10).
• Presence of psychosis
• Cognitive impairment sufficient to impair ability to give informed consent.
• Current pregnancy, or inability to utilize contraception
• The presence of any metallic implants
• History of claustrophobia

Contacts and Locations

Locations

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Tufts Medical Center

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Nassir Ghaemi, MD, MPH; Tufts University Medical

More Information

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT00562861 History of Changes
• Other Study ID Numbers: MH78060-01A1; 5R01MH078060-04 ( U.S. NIH Grant/Contract )
• First Posted: November 22, 2007
• Results First Posted: February 13, 2017
• Last Update Posted: March 24, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Tufts Medical Center:

Bipolar Disorder; Bipolar Depression; Clinical Trials, Phase II; Clinical Pharmacology

Additional relevant MeSH terms:

Carbamazepine; Valproic Acid; Depression; Depressive Disorder; Bipolar Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Lamotrigine; Dexetimide; Citalopram; Antidepressive Agents; Psychotropic Drugs; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antimanic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Antipsychotic Agents; Sodium Channel Blockers; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Neurotransmitter Agents; Serotonin Agents