NCT00976794

Brief Summary

The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

3.4 years

First QC Date

September 11, 2009

Last Update Submit

July 10, 2013

Conditions

Bipolar I Disorder

Keywords

BD I

Outcome Measures

Primary Outcomes (1)

  • The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study.

    August 2012

Secondary Outcomes (1)

  • Secondary outcome will include the proportion of patients that had response but not remission to each treatment at the end of each phase of the study

    August 2012

Study Arms (2)

lithium plus carbamazepine

EXPERIMENTAL

combination of the two drugs in standard dosage

Drug: lithium plus carbamazepine

lithium plus valproate

ACTIVE COMPARATOR

combination of the two drugs in standard dosage

Drug: lithium plus valproate

Interventions

lithium plus carbamazepineDRUG

Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability. Carbamazepine : Starting at 200mg daily and getting 600 mg daily at the end of the first week. Dose weekly adjusted according to blood serum level (8 and 12µg/ml), efficacy and tolerability

lithium plus carbamazepine
lithium plus valproateDRUG

Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability. Valproic acid: Starting at 500mg daily, dose weekly adjusted according to blood serum level (50 and 125µg/ml), efficacy and tolerability.

lithium plus valproate

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
  • The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.

You may not qualify if:

  • Schizophrenia or schizoaffective disorder
  • Mental retardation
  • Unstable clinical diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry - University of São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (3)

  • Fountoulakis KN, Vieta E, Sanchez-Moreno J, Kaprinis SG, Goikolea JM, Kaprinis GS. Treatment guidelines for bipolar disorder: a critical review. J Affect Disord. 2005 May;86(1):1-10. doi: 10.1016/j.jad.2005.01.004.

    PMID: 15820265BACKGROUND

  • Missio G, Moreno DH, Demetrio FN, Soeiro-de-Souza MG, Dos Santos Fernandes F, Barros VB, Moreno RA. A randomized controlled trial comparing lithium plus valproic acid versus lithium plus carbamazepine in young patients with type 1 bipolar disorder: the LICAVAL study. Trials. 2019 Oct 26;20(1):608. doi: 10.1186/s13063-019-3655-2.

    PMID: 31655626DERIVED

  • Campos RN, Costa LF, Bio DS, Soeiro de Souza MG, Garcia CR, Demetrio FN, Moreno DH, Moreno RA. LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder. Trials. 2010 Jun 23;11:72. doi: 10.1186/1745-6215-11-72.

    PMID: 20573223DERIVED

MeSH Terms

Interventions

LithiumCarbamazepineValproic Acid

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

BR(1)