Trial intelligence / Profile preview

Nizatidine for Olanzapine-Induced Weight Gain in Schizophrenia

NCT00486005Phase 4

Key facts

Status
Completed
Start
Feb 2003
Countries
1
Modality
Small Molecules
01

Overview

Phase 4, randomised, double-blind trial comparing Nizatidine + Olanzapine with Placebo + Olanzapine (2 arms). Primary endpoint: Weight Gain. Started Feb 2003; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Nizatidine + Olanzapine

    Nizatidine added to ongoing Olanzapine therapy

  • Placebo + Olanzapine

    Placebo added to ongoing Olanzapine therapy

03

Who it enrols

Patients with schizophrenia aged 18-65 who have been on olanzapine (5-20 mg/day) for 2-6 months and have experienced at least a 5% weight gain.

04

Endpoints

Primary

  • Weight Gain

Secondary

  • Cognitive Control of Appetite

  • Brief Psychiatric Rating Scale

  • Adverse Events

  • Vital Signs

  • Laboratory Results

  • Extrapyramidal Symptoms

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