Open Label Study of Lithium Plus Extended-Release Carbamazepine (ERC-CBZ) for Rapid Cycling Bipolar Disorder

NCT00325286 | Unknown Phase 4

• 1 other identifier: 05-13934
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label design using Lithium plus extended release carbamazepine (Equetro) in combination for 6 months. Rapid cycling bipolar disorder is frequently treatment refractory and associated with repeated hospitalizations and complications. The results of this study will offer a promising approach to treat this complex disorder. The primary efficacy measure will be the time to relapse. Relapse will determined by the investigator based on the following: Need for additional pharmacotherapy for mood-related symptoms, hospitalization for an mood episode, increase of more than 50% in HAM-D and YMRS scores from the baseline visit.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• The primary efficacy measure will be the time to relapse. Relapse will determined by; need for additional pharmacotherapy, hospitalization for an affective episode, increase of >/= 50% in HAM-D and YMRS scores.

  Patients will be seen weekly during preliminary phase and biweekly during the open label phase

Secondary Outcomes (1)

• The differences in the frequency of affective episodes in the 6-month prior to the treatment with ERC-CBZ and 6 months after treatment initiation will also be measured. Secondary efficacy measures will include; changes in the 17- Item Hamilton Depression

  Patients will be seen weekly during the preliminary phase and biweekly during the open label phase

Study Arms (1)

1

EXPERIMENTAL

Treatment with lithium and extended release carbamazepine

Drug: Lithium Plus Extended- Release Carbamazepine

Interventions

Lithium Plus Extended- Release Carbamazepine DRUG

Preliminary phase subjects receive ERC-CBZ starting dose range from 100 to 200 mg b.i.d. and further titration up to a maximum dose of 1600 mg/day done at the discretion of the investigator. Titration phase will not extend beyond 2 weeks.Open label phase subjects stabilized on lithium and ERC-CBZ therapy will enter this phase for 6 months

Also known as: Epitol, Tegretol

1

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, 19 years and older with DSM-IV defined Bipolar Disorder with a history of the rapid cycling within the past 12 months.
• Subjects may be either in a manic, mixed or depressive phase at time of study entry.
• Subjects must be on lithium therapy for 6 months or longer. Stable lithium therapy will be defined as: No changes in lithium dosage for at least 2 weeks prior to study entry and a therapeutic lithium level (0.6 to 1.2 mEq) prior to study entry.

You may not qualify if:

• Subjects with a lifetime history of Schizophrenia or Schizoaffective Disorder
• If patients are on thyroid replacement therapy they have to on stable doses for the past 3 months at study enrollment.
• Presence of active suicide ideations or score of \> 3 on the suicide subscale of the 17 - item HAM-D.
• Current substance dependence (excluding nicotine) defined as no dependence criteria for 30 days prior to study enrollment
• Subjects with a history of non-response to carbamazepine or lithium
• Subjects who are pregnant or planning to become pregnant
• Subjects with a history of allergic/idiosyncratic reaction or intolerability to carbamazepine or lithium.

Sponsors & Collaborators

• Creighton University: lead
• Shire: collaborator

Study Sites (1)

Creighton University Department of Psychiatry

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium; Carbamazepine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sriram Ramaswamy, M.D.

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2006
• First Posted: May 12, 2006
• Study Start: May 1, 2006
• Study Completion: March 1, 2008
• Last Updated: December 14, 2007

Record last verified: 2007-12

Locations

US (1)