Treatment Study of Bipolar Depression

NCT00947791 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: GCO 08-1422
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Depression; Treatment-Resistant; ketamine; antidepressant; glutamate

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  24 hrs post-infusion compared to baseline

Secondary Outcomes (5)

• Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)

  24 hrs post-infusion compared to baseline

• Young Mania Rating Scale (YMRS)

  24 hrs post-infusion compared to baseline

• Brief Psychiatric Rating Scale (BPRS)

  4 hrs post-infusion compared to baseline

• Clinician-Administered Dissociative States Scale (CADSS)

  4 hrs post-infusion compared to baseline

• Systematic Assessment for Treatment Emergent Effects (SAFTEE)

  4 hrs post-infusion compared to baseline

Study Arms (2)

Ketamine/Midazolam

EXPERIMENTAL

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

Midazolam/Ketamine

EXPERIMENTAL

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

ketamine DRUG

a single IV infusion of ketamine, IV 0.5 mg/kg

Ketamine/Midazolam; Midazolam/Ketamine

midazolam DRUG

a single IV infusion of midazolam, 0.045 mg/kg

Ketamine/Midazolam; Midazolam/Ketamine

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. James W. Murrough
• Organization: Icahn School of Medicine at Mount Sinai

james.murrough@mssm.edu

212-241-6539

Study Officials

• James W Murrough, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patient, doctor and rater are masked (triple masked). Only the research pharmacist is unblinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 17, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-04

Locations

US (1)