TerminatedNCT00947791Updated May 17, 2017Results posted

Treatment Study of Bipolar Depression

A Phase 4 interventional study of ketamine and midazolam in Bipolar Disorder, sponsored by Icahn School of Medicine at Mount Sinai. Terminated at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Treatment

Why this study was terminated

Change in available resources for study procedures

Phase: Phase 4
Study type: Interventional
Enrollment: 1
Allocation: Randomized
Ages: 21 Years to 70 Years
Sex: All

Study summary

The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.

Read the detailed description

Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with this devastating condition. Despite the high degree of morbidity and mortality associated with bipolar depression, currently available treatments are few and often inadequate. Recently, a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine has demonstrated rapid antidepressant effects in severe unipolar depression. Therefore, the objective of the current study is to investigate the safety and efficacy of a single IV dose of ketamine in treatment-resistant bipolar depression (TRBD).

Conditions studied

Bipolar Disorder

Browse trials for

Keywords

Bipolar Disorder
Depression
Treatment-Resistant
ketamine
antidepressant
glutamate

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 1 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female patients, 21-70 years;
Primary diagnosis of bipolar I or II disorder as assessed by the SCID-P and confirmed by a study psychiatrist;
Current depressive episode ≥ 8 weeks duration;
History of a failure to respond to at least three (3) adequate pharmacotherapy trials in the current depressive episode (see above for definition for adequate trials);
Subjects must be on a stable dose of divalproex ER with serum levels greater than 55 mcg/ml prior to enrollment;
Subjects must be free of psychotropic medication for at least 2 weeks (4 weeks for fluoxetine) prior to enrollment (with the exception of divalproex ER as above);
Subjects must have scored ≥ 32 on the IDS-C30 at both Screening and Infusion Day #1 and #2;

Exclusion criteria

Exclusion Criteria:

Women who plan to become pregnant, are pregnant or are breast-feeding;
Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease;
Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG;
Lifetime history of schizophrenia, schizoaffective disorder, OCD, mental retardation, pervasive developmental disorders, or Tourette's syndrome;
Current presence of psychotic, mixed or manic symptoms;
Lifetime history of antidepressant-induced switch to a manic episode;
History of rapid cycling bipolar subtype;
Drug or alcohol abuse within the preceding 3 months or dependence within the preceding 5 years;
Lifetime exposure to ketamine or phencyclidine;
Patients judged by study investigator to be at high risk for suicide.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 1 participant (actual)

Study arms

Experimental
Ketamine/Midazolam
Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to ketamine-midazolam. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart.
Drug: ketamine · Drug: midazolam
Experimental
Midazolam/Ketamine
Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to midazolam-ketamine. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart.
Drug: ketamine · Drug: midazolam

Interventions

Drugketamine
a single IV infusion of ketamine, IV 0.5 mg/kg
Drugmidazolam
a single IV infusion of midazolam, 0.045 mg/kg

What researchers measure

Primary outcomes

Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 24 hrs post-infusion compared to baseline

Secondary outcomes

Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)
Time frame: 24 hrs post-infusion compared to baseline
Young Mania Rating Scale (YMRS)
Time frame: 24 hrs post-infusion compared to baseline
Brief Psychiatric Rating Scale (BPRS)
Time frame: 4 hrs post-infusion compared to baseline
Clinician-Administered Dissociative States Scale (CADSS)
Time frame: 4 hrs post-infusion compared to baseline
Systematic Assessment for Treatment Emergent Effects (SAFTEE)
Time frame: 4 hrs post-infusion compared to baseline

Results

Posted May 17, 2017

Participant flow

Participant flow — Overall Study
Milestone	Ketamine/Midazolam	Midazolam/Ketamine
Started	0	1
Completed	0	1
Not completed	0	0