MedDataX Logo

Tryptophan Depletion in Acute Mania

NCT ID: NCT00192725

Last Updated: 2010-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Serotonin (5-HT) is important in mood regulation and is believed to play a major role in the pathophysiology of major depression (MD). Selective serotonin reuptake inhibitors (SSRIs) are currently the most widely used drugs for the treatment of depression. Patients with bipolar disorder (BD) who are treated for depression with SSRIs might develop mania, which is believed to be triggered by antidepressant treatment. Rapid tryptophan depletion (RTD) has been shown to induce transient depressive symptoms in remitted depressed patients treated with SSRIs. In remitted manic patients treated with lithium, RTD does not seem to have clinical effects. However, RTD was not studied in acutely manic patients and could theoretically have antimanic properties. In this double blind randomized placebo controlled study RTD will be used as a tool to assess the role of 5-HT in mania and will be evaluated for its antimanic properties and potential use as augmentation to drug treatment in acute mania.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tranylcypromine Treatment of Bipolar Depression

NCT01430455

Bipolar Disorder I or II
COMPLETED PHASE4

Efficacy of Adjunctive Tianeptine in the Treatment of Bipolar Depression

NCT00879372

Bipolar Disorder
UNKNOWN PHASE3

Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression

NCT06506019

Bipolar Depression
RECRUITING PHASE1

A Placebo Controlled Trial of the Dopamine D-2 Receptor Agonist Ropinirole in Treatment of 60 Patients With Refractory Bipolar Depression.

NCT00335205

Bipolar Disorder Major Depressive Disorder
UNKNOWN PHASE4

Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging

NCT02473250

Bipolar Disorder
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rapid tryptophan depletion

Amino-acid mixture without tryptophan

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Acute mania
* Ability to provide written informed consent

Exclusion Criteria

* Mixed affective states
* Suicidal ideation
* Uncontrolled systemic illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beersheva Mental Health Center

OTHER_GOV

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rambam Medical Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ehud Klein

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rambam Medical Center

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

tryp.dep.maniaCTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bipolar Depression Before and After Lamotrigine Treatment
NCT01042496 COMPLETED PHASE3
Valnoctamide in Mania
NCT00140179 COMPLETED PHASE3
Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
NCT00562861 COMPLETED PHASE2/PHASE3
Psychosocial Therapy Plus Maintenance Pharmacotherapy for Treating Bipolar Disorder
NCT00227968 COMPLETED PHASE4
Bipolar II Depression: Lithium, SSRI, or the Combination
NCT00276965 COMPLETED PHASE3
Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder
NCT01322113 COMPLETED
Depression And Bipolar Disorder
NCT00274677 COMPLETED PHASE3
A Study of the Association Between Tobacco Smoking and Bipolar Affective Disorder
NCT00741299 COMPLETED
Liothyronine (T3) for Bipolar Depression
NCT00790738 COMPLETED PHASE3
Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study
NCT00177567 COMPLETED PHASE4
PET and MRI Brain Imaging of Bipolar Disorder
NCT01880957 COMPLETED NA
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
NCT04433845 UNKNOWN PHASE2
Bupropion SR for Major Depression and Depression NOS in Children and Adolescents With Bipolar Disorder
NCT00181896 TERMINATED PHASE4
Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
NCT00608075 UNKNOWN PHASE4
Examination of Tamoxifen in Acute Mania in Patients With Bipolar I Disorder
NCT00026585 COMPLETED PHASE2
Brain Derived Neurotrophic Factor as a Predictor of Response to Treatment in Bipolar Depression and Mania
NCT00879632 UNKNOWN
Testing the Ability of JNJ-18038683 to Improve Cognition and Reduce Depressive Symptoms in Stable Bipolar Patients
NCT02466685 COMPLETED PHASE2
Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil
NCT01965925 COMPLETED PHASE4
The Effect of Methylphenidate on Cognitive Abilities of Adults With Bipolar Disorder
NCT02020200 UNKNOWN NA
Lamotrigine Alone Compared to Lamotrigine Plus Antidepressant for the Treatment of Bipolar II Depression
NCT00475137 COMPLETED PHASE2
Change in Brain Bioenergetics in Bipolar Disorder in Response to Photic Stimulation
NCT00801567 WITHDRAWN NA
Oral Uridine for Treatment of Bipolar Depression in Adolescents
NCT00841269 COMPLETED PHASE2
Risk Factors for AD-Associated Switch to Mania
NCT01503489 COMPLETED
Functional and Neurochemical Brain Changes Bipolar Depression
NCT00608296 COMPLETED
The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
NCT05973786 RECRUITING PHASE3